Prosecution Insights
Last updated: July 26, 2026
Application No. 18/131,821

DIGITAL ANALYSIS OF MOLECULAR ANALYTES USING SINGLE MOLECULE DETECTION

Final Rejection §DP
Filed
Apr 06, 2023
Priority
Nov 19, 2012 — provisional 61/728,067 +4 more
Examiner
TSUI, YUNG-SHENG M
Art Unit
1684
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Illumina Cambridge Limited
OA Round
2 (Final)
66%
Grant Probability
Favorable
3-4
OA Rounds
0m
Est. Remaining
73%
With Interview

Examiner Intelligence

Grants 66% — above average
66%
Career Allowance Rate
355 granted / 536 resolved
+6.2% vs TC avg
Moderate +7% lift
Without
With
+6.8%
Interview Lift
resolved cases with interview
Typical timeline
2y 10m
Avg Prosecution
41 currently pending
Career history
568
Total Applications
across all art units

Statute-Specific Performance

§101
0.7%
-39.3% vs TC avg
§103
60.3%
+20.3% vs TC avg
§102
15.3%
-24.7% vs TC avg
§112
10.2%
-29.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 536 resolved cases

Office Action

§DP
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 . DETAILED ACTION Status of the Claims Claims 29, 31, 35-37 and 39-43 are pending and the subject of this FINAL Office Action. Double Patenting- Obvious Type The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b). Instant claims 29, 31, 35-37 and 39-43 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over conflicting claims 1-13 of U.S. Patent No. 11,248,266 (identical inventors and assignee to this application), in view of RAMSING (US 20050089889). The instant claims are obvious over the conflicting claims because the conflicting claims anticipate the instant claims. Specifically, the conflicting claims teach the same probes as claimed, used in a method: 1. A method for detecting a plurality of analytes in a biological sample, wherein each distinct target analyte of N distinct target analytes is immobilized on a solid substrate in a location that is spatially separate from any other distinct target analyte of said N distinct target analytes, the method comprising: selecting sets of fluorescently tagged probes comprising X distinct colors, wherein each of said probes is detectably labelled such that one probe is configured to detect one distinct target analyte; performing at least M cycles of single molecule detection, each cycle comprising one or more passes; wherein each pass comprises selective binding between said probes and said N distinct target analytes and signal detection; wherein each cycle further comprises stripping of said probes from said substrate; detecting from each of said at least M cycles a presence or an absence of a plurality of signals from said spatially separate locations of said substrate; and determining from said plurality of signals information about a presence or absence of one or more of said X colors for each of said N distinct target analytes in each of said passes of said cycle; and encoding said information into at least K bits of information using an error correcting code, combining said K bits of information into L=K×M bits of total information so that L bits of information describe a presence or absence of one or more of said N distinct target analytes; wherein K, M and X are chosen so that XM>N, L>log 2 (N); and wherein said M cycles comprise one or more additional cycles to account for errors in said detected signals by generating additional bits of information compared to the minimum number of bits of information required to identify said N distinct analytes. 2. The method of claim 1, wherein a detectable signal is generated through binding of a single probe to said one distinct target analyte. 3. The method of claim 1, wherein L>log 2 (N), and wherein L comprises bits of information for target identification. 4. The method of claim 1, further comprising digitizing said plurality of signals to expand a dynamic range of detection of said plurality of signals. 5. The method of claim 1, wherein said at least K bits of information comprise information about an absence of a signal for one of said N distinct target analytes. 6. The method of claim 1, wherein said probes comprise an aptamer. 7. The method of claim 6, wherein said aptamer comprises a homopolymeric base region. 8. The method of claim 1, wherein said plurality of analytes comprises a protein, a peptide aptamer, or a nucleic acid molecule, or wherein said detecting from said at least M cycles said presence or absence of said plurality of signals comprises optically detecting said plurality of signals, or wherein said detecting from said at least M cycles said presence or absence of said plurality of signals comprises electrically detecting said plurality of signals. 9. The method of claim 1, wherein said additional bits of information generated to account for errors are parity bits. 10. The method of claim 1, wherein said error correction code comprises using a Reed-Solomon code. 11. The method of claim 1, wherein said N distinct target analytes are present in a sample, and wherein said sample is divided into a plurality of aliquots that are diluted to a plurality of distinct final dilutions, each of said plurality of aliquots being immobilized onto a distinct section of said substrate. 12. The method of claim 11, wherein a concentration of one of said N distinct target analytes is determined by counting the occurrences of a target analyte within one of said distinct sections and adjusting a count according to said dilution of said respective aliquot. 13. The method of claim 1, wherein said probes comprise an antibody. A skilled artisan would have been well-aware of the simple, easy option to include this method in instructions for a computer as is very commonly done in the art (RAMSING, para. 0091 – “As for the probe selection method, the selection method for detection means can be provided to the end-user as a computer program product providing instructions for implementing the method, embedded in a computer-readable medium. Consequently, the invention also provides for a system comprising a database of nucleic acid probes of the invention and an application program for executing this computer program.”). Thus, the method of these conflicting claims in computer instructions is obvious. Conclusion No claims are allowed. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MELODY TSUI whose telephone number is (571)272-1846. The examiner can normally be reached Monday - Friday, 9am - 5pm. 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, Heather Calamita can be reached at 571-272-2876. 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. /YUNG-SHENG M TSUI/ Primary Examiner, Art Unit 1684
Read full office action

Prosecution Timeline

Apr 06, 2023
Application Filed
Aug 30, 2024
Response after Non-Final Action
Feb 05, 2026
Non-Final Rejection mailed — §DP
May 05, 2026
Response Filed
May 26, 2026
Final Rejection mailed — §DP (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

3-4
Expected OA Rounds
66%
Grant Probability
73%
With Interview (+6.8%)
2y 10m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 536 resolved cases by this examiner. Grant probability derived from career allowance rate.

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