Prosecution Insights
Last updated: October 02, 2026
Application No. 18/279,319

DEVICES AND METHODS FOR ELECTROPHORETIC EXTRACTION OF NUCLEIC ACIDS FROM BIOLOGICAL SAMPLES

Non-Final OA §102§103
Filed
Aug 29, 2023
Priority
Mar 03, 2021 — provisional 63/155,940 +1 more
Examiner
DEES, NIKKI H
Art Unit
1691
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Roche Sequencing Solutions Inc.
OA Round
1 (Non-Final)
22%
Grant Probability
At Risk
1-2
OA Rounds
1y 3m
Est. Remaining
43%
With Interview

Examiner Intelligence

Grants only 22% of cases
22%
Career Allowance Rate
140 granted / 638 resolved
-38.1% vs TC avg
Strong +21% interview lift
Without
With
+20.7%
Interview Lift
resolved cases with interview
Typical timeline
4y 4m
Avg Prosecution
21 currently pending
Career history
654
Total Applications
across all art units

Statute-Specific Performance

§101
2.6%
-37.4% vs TC avg
§103
48.1%
+8.1% vs TC avg
§102
11.5%
-28.5% vs TC avg
§112
26.4%
-13.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 638 resolved cases

Office Action

§102 §103
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 . Election/Restrictions Applicant’s election without traverse of Claims 1-13 in the reply filed on 02/12/2026 is acknowledged. In response to the election of species requirement, Applicant elects the following: Species A: nucleic acids; Species B: cylindrical collection chambers (claim 4); Species C: the sieving matrix is in the top reservoir (claim 6); Species D: the semi-permeable membrane is in the collection chamber (claim 8); and Species E: the top reservoir comprises a buffer with a leading electrolyte and the bottom reservoir comprises a buffer with a trailing electrolyte (claim 13), which is generally specific to epitachophoresis. These elections reads on claims 1-4, 6, 8, 10-11, and 13. Claims 14- withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected a method of extracting biological polymers and an assembly for isolating biological polymers, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/12/2026. Claim Rejections - 35 USC § 102 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. Claims 1-3, 6, 8, 11, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20200325467 A1, henceforth referred to as "Mather". Below is an annotated figure 18 from Mather: PNG media_image1.png 553 549 media_image1.png Greyscale Below is an annotated figure 1 from the present application: PNG media_image2.png 537 473 media_image2.png Greyscale In regard to claim 1, Mather teaches a fluidic device comprising: in [0219] a top reservoir comprising a sample chamber, slide layer, and membrane layer which shown in figure 18 to be on top, items 203A, 1708, and 1704. in [0219] an elution chamber shown in figure 18 to be on the bottom, item 203B. Further described in [0194] to have a membrane that create a physical barrier between eluted nucleic acids (biological polymers) in the elution chamber and the electrode. That is, the elution chamber comprises two separate reservoirs that are not depicted in figure 18, the lower of which is the bottom reservoir and the higher of which is the collection chamber. The collection chamber being situated between the top and bottom reservoir, operably connected to both. in [0219] a filter (sieving matrix) shown in figure 18, item 280', that allows nucleic acids (biological polymers) to pass through in [0194] membranes (semi-permeable membranes) used to create a physical barrier between eluted nucleic acids (biological polymers) in the elution chamber and the electrode in [0181] and figure 5A a pair of electrodes, items 264 and 266, positioned above and below the fluidic device, item 202 In regard to claims 2 and 3, Mather teaches in [0187] and figure 5A that there is a pair of electrodes, items 264 and 266, positioned above and below the fluidic device, item 202. The electrode above the fluidic device is the cathode (working electrode) and the electrode below the fluidic device is the anode (counter electrode). Further in regard to claim 3, Mather teaches in [0187] and figure 5A that there is a pair of electrodes, items 264 and 266, positioned above and below the fluidic device, item 202 and the electrode below the fluidic device is the anode (counter electrode). As described in the rejection to claim 1 and Mather's [0194], the elution chamber is separated into a collection chamber and a bottom reservoir by a membrane, with the bottom chamber comprising an electrode. In regard to claim 6, Mather teaches in [0219] a filter (sieving matrix) shown in figure 18, item 280', that allows nucleic acids (biological polymers) to pass through and is located in the top reservoir (as described in the above rejection to claim 1). In regard to claim 8, Mather teaches in [0194] membranes (semi-permeable membranes) used to create a physical barrier between eluted nucleic acids (biological polymers) in the elution chamber and the electrode. Therefore, since the membrane defines a boundary for the collection chamber, it is a part of the collection chamber. In regard to claim 11, Mather teaches in [0213] that there is an elution buffer in chamber 203A (top reservoir) and in [0216] that buffers are present in the sample chamber 203B (which contains the bottom reservoir). In regard to claim 13, Mather teaches in [0213] that there is an elution buffer in chamber 203A (top reservoir) and in [0216] that buffers are present in the sample chamber 203B (which contains the bottom reservoir). No specifics for what comprises a leading or a trailing electrolyte are given in the claims or specification of the present application and so the electrolytes used in the buffer solutions are considered to meet the claimed leading and trailing electrolytes. 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. 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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Mather. Mather teaches the device as set forth above with regard to claim 1. Mather does not teach that the collection chamber is cylindrical. However, per MPEP 2144.04 IV (B) changes in shape are obvious absent persuasive evidence that the particular configuration of the claimed container is significant and the microperforated region of Mather, figure 18 item 1710 is a collection chamber and the shape being cylindrical would not provide a patentable distinction. A person having ordinary skill in the art would have expected Mather’s chamber to continue to function as described regardless of its shape being a rectangular prism or a cylinder. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Mather in view of US 20180202968 A1, henceforth referred to as "Singer". Below is an annotated figure 3 from Singer. PNG media_image3.png 638 672 media_image3.png Greyscale Mather teaches a semi-permeable membrane and a sieving matrix in their fluidic device as described in the rejection of claim 1. Mather fails to teach the relative MWCO of their semi-permeable membrane and sieving matrix. Singer teaches in [0066] that the closing matrix (semi-permeable membrane) has a pore size larger than the pore size of the collection matrix (sieving matrix) which means the MWCO of the semi-permeable membrane is larger than the sieving matrix. Singer further teaches that this configuration of MWCOs can support the pressure equalization in the passage [0066], preventing an overflow of running solution out of the passage. It would have been obvious to a person having ordinary skill in the art to have the MWCO of Mather’s semi-permeable membrane being greater than the MWCO of their sieving matrix to support the pressure equalization and prevent overflow of running solution. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY SABATOSE whose telephone number is (571)272-9893. The examiner can normally be reached 8:00-6:00 M-Th. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nikki Dees can be reached at 571-270-3435. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /A.C.S./ Examiner, Art Unit 1791 /Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
Read full office action

Prosecution Timeline

Aug 29, 2023
Application Filed
Aug 20, 2026
Non-Final Rejection mailed — §102, §103 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
22%
Grant Probability
43%
With Interview (+20.7%)
4y 4m (~1y 3m remaining)
Median Time to Grant
Low
PTA Risk
Based on 638 resolved cases by this examiner. Grant probability derived from career allowance rate.

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