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 .
Applicant previously canceled claims 1-124. Claims 125-139 are currently pending and under examination.
Information Disclosure Statement
The Information Disclosure Statements filed February 05, 2024; October 31, 2024; February 26, 2025; March 07, 2025; April 08, 2025; and June 26, 2025 have been considered.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 125-130 and 133-139 are rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by Jebrail et al. (WIPO International Application Publication WO 2016/197106 A1, published December 08, 2016), cited on the IDS filed February 05 2024.
Regarding claim 125, Jebrail teaches a method for droplet processing, comprising: a. providing an electrowetting array (Pages 2-3, [009]-[0010] and Pages 4-5, [0018]). Jebrail teaches dispensing a droplet adjacent to said electrowetting array (Page 7, [0031] and Page , [0070]). Jebrail teaches subjecting said droplet to conditions sufficient to perform a chemical reaction, biological reaction, or biochemical reaction within said droplet while said droplet is adjacent to said electrowetting array (Pages 2-3, [009], Pages 3-4, [0013], Pages 4-5, [0018] and Page 7, [0029]). Jebrail teaches during said chemical reaction, biological reaction, or biochemical reaction, a volume of said droplet is maintained to within about 20% of a threshold volume, and said threshold volume is based on said chemical reaction, biological reaction, or biochemical reaction (Pages 3-4, [0013], Page 5, [0020]-[0021], Page 17, [0077] and Page 18, [0080]).
Regarding claim 126, Jebrail teaches said electrowetting array comprises one or more electrodes (Pages 4-5, [0018] and Pages 8-9, [0038]).
Regarding claim 127, Jebrail teaches a temperature sensor is coupled to a side of said electrowetting array (Page 8, [0037], Pages 14-15, [0067] and Figure 7).
Regarding claim 128, Jebrail teaches providing a temperature control element external to said electrowetting array (Page 7, [0030]-[0031], Page 8, [0037], Page 11, [0056], Pages 14-15, [0067] and Figure 7) .
Regarding claim 129, Jebrail teaches an original volume of said droplet and said threshold volume differ by at most about 10% (Page 5, [0020]-[0021] and Page 6, [0024].
Regarding claim 130, Jebrail teaches an original volume of said droplet and said threshold volume differ by at most about 5% (Page 5, [0021]).
Regarding claim 133, Jebrail teaches an original volume of said droplet and a threshold volume of said droplet differ by at most about 5% over a time period of at least 10 seconds (Page 5, [0021] and Page 15, [0070]).
Regarding claim 134, Jebrail teaches during said chemical reaction, biological reaction or biochemical reaction, a module in fluid communication with said electrowetting array is used to provide a liquid to said droplet to maintain said volume to within 20% of said threshold volume (Pages 3-4, [0013], Page 5, [0020]-[0021], Page [0038], Page 17, [0077] and Page 18, [0080]).
Regarding claim 135, Jebrail teaches said module dispenses a replenishing droplet when said volume and said threshold volume differ by greater than about 20% (Pages 4-5, [0018]-[0021] and Page 6, [0024]).
Regarding claim 136, Jebrail teaches providing one or more humidity sensors adjacent to said electrowetting array (Page 2, [007] and [009] and Page 7, [0030] .
Regarding claim 137, Jebrail teaches using one or more sensors to detect a change in said volume of said droplet (Abstract and Page 7, [0030]).
Regarding claim 138, Jebrail teaches said chemical reaction, said biological reaction, or said biochemical reaction is a nucleic acid isolation to generate a nucleic acid fragment (Pages 3-4, [0013], Page 10, [0046], Pages 19-20, [0085] and Example 2).
Regarding claim 139, Jebrail teaches said replenishing droplet is dispensed directly onto said droplet or onto said electrowetting array (Pages 4-5, [0018]-[0020], Page 7, [0029], Pages 8-9, [0038], Page 15, [0070], Page 16, [0072] and Page 22, [0091]). Jebrail teaches said electrowetting array is used to merge said droplet with said replenishing droplet (Pages 4-5, [0018]-[0020], Page 7, [0029], Page 16, [0072] and Page 19, [0082]).
Jebrail teaches each and every claim limitation of claims 125-130 and 133-139, therefore Jebrail anticipates claims 125-130 and 133-139.
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.
Claims 131 and 132 are rejected under 35 U.S.C. 103 as being unpatentable over Jebrail et al. (WIPO International Application Publication WO 2016/197106 A1, published December 08, 2016), cited on the IDS filed February 05 2024, as applied to claims 125-130 and 133-139 above.
Regarding claims 131and 132, Jebrail teaches an original volume of said droplet and said threshold volume differ as discussed above. Jebrail teaches the volume of the replenishing droplet may be scaled or adjusted so as not to disrupt the reaction (Page 5, [0021]). Jebrail additionally teaches the air-matrix DMF apparatus may be configured or calibrated for different droplet volumes to detect and/or different thresholds of volume reduction/evaporation to trigger replenishing, e.g., when the droplet has decreased by a certain percentage (i.e., the user may choose to set the apparatus to detect any amount of droplet volume change or threshold of volume change to trigger replenishing, such as an original volume of a droplet and a threshold volume differing at the most by 0.01% or 1%, Page 18, [0080]).
Jebrail does not explicitly teach or suggest an original volume of said droplet and said threshold volume differ by at most about 1%. Jebrail does not explicitly teach or suggest an original volume of said droplet and said threshold volume differ by at most about 0.01%.
However, it would have been prima facie obvious to one of ordinary skill in the art before the invention was made to have chosen an original volume of a droplet and a threshold volume differing by at most about 1% or 0.01% because Jebrail teaches that the apparatus used in the methods may be calibrated or set to detect droplet volume change and/or threshold of volume change to trigger replenishing (i.e., designed by user’s choice). Jebrail additionally teaches the volume of the replenishing droplet may be scaled or adjusted so as not to disrupt the reaction. Therefore, depending on the reaction chosen one could set the apparatus used in Jebrail to any chosen initial volume and any chosen threshold volume to differ any amount in order to trigger replenishing and changing the volume of the droplet so as not to disrupt the reaction without surprising or unexpected results.
Claims 131 and 132 are rejected under 35 U.S.C. 103 as being unpatentable over Jebrail et al. (WIPO International Application Publication WO 2016/197106 A1, published December 08, 2016), cited on the IDS filed February 05 2024, as applied to claims 125-130 and 133-139 above, in view of Pollock et al. (U.S. Patent 7,851,184 B2, published November 26, 2009, patented December 14, 2010).
Regarding claims 131and 132, Jebrail teaches an original volume of said droplet and said threshold volume differ as discussed above.
Jebrail does not explicitly teach or suggest an original volume of said droplet and said threshold volume differ by at most about 1%. Jebrail does not explicitly teach or suggest an original volume of said droplet and said threshold volume differ by at most about 0.01%.
Pollock teaches droplet processing comprising an electrowetting array (Column 57, Lines 37-44, Column 59, Lines 5-6 and column 61, Lines 51-64). Pollock teaches subjecting the droplet to conditions sufficient to perform a chemical or biochemical reaction within the droplet adjacent to said electrowetting array (Column 86, Lines 64-66, Column 20, Lines 31-51, Column 58, Lines 49-60 and Column 64, Lines 54-57). Pollock teaches the initial volume and the threshold volume differing by about 0.001% to about 10% (Column 65, Lines 40-53 and Column 53, Lines 8-36). Pollock teaches a replenishing filler fluid as well as maintaining a droplet threshold volume (Column 62, Line 49—Column 63, Line 8 and Column 67, Lines 13-24). Pollock teaches merging droplets (Column 71, Lines 12-16). Pollock teaches using these methods includes the advantages of faster kinetics, reduces time for the assays and higher throughput due to multiplexing as well as accurately and reproducibly dispense droplets of a solution of known concentration of control analyte and can dilute such droplets by combining them with buffer droplets to provide a series of control droplets having varied concentrations of control analyte to produce a calibration curve to determine quantities of a wide variety of analytes in sample droplets (Column 41, Lines 5-15 and Line 64—Column 42, Line 29).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Jebrail with the teachings of Pollock, using the initial volume and the threshold volume differing by about 0.001% or 1% . Using these methods allows for the advantages of faster kinetics, reduces time for the assays and higher throughput due to multiplexing as well as accurately and reproducibly dispense droplets of a solution of known concentration of control analyte and can dilute such droplets by combining them with buffer droplets to provide a series of control droplets having varied concentrations of control analyte to produce a calibration curve to determine quantities of a wide variety of analytes in sample droplets as taught by Pollock (Column 41, Lines 5-15 and Line 64—Column 42, Line 29).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA DANIELLE PARISI whose telephone number is (571)272-8025. The examiner can normally be reached Mon - Friday 7:30-5:00 Eastern with alternate Fridays off.
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/JESSICA D PARISI/ Examiner, Art Unit 1684
/HEATHER CALAMITA/ Supervisory Patent Examiner, Art Unit 1684