Prosecution Insights
Last updated: October 02, 2026

Roche Diagnostics Operations Inc.

Technology areas: Biotechnology & Pharmaceuticals • Chemistry & Materials

61 pending office actions • 28 art units • 52 examiners • 0 of 61 (0%) have an AI response strategy ready • 65 patents granted in the last 365 days

Analysis

Roche Diagnostics Operations Inc. maintains a large portfolio of 59 pending office actions within the Biotechnology & Pharmaceuticals technology area. These actions are distributed among 51 distinct examiners, indicating a high level of diversification in the examination process. With the examiners reviewing 59 actions, the company faces a wide array of examiner styles and preferences that could impact the speed and success of patent grants.

The portfolio's reach extends across 27 distinct art units, reflecting the broad technical scope of the company's innovations in Biotechnology & Pharmaceuticals. This count of 27 distinct art units suggests that the pending office actions cover a diverse range of sub-technologies, each with its own set of examination challenges. Managing such a distributed portfolio requires a sophisticated approach to maintain consistency across many different administrative environments.

SINES, BRIAN J is the busiest examiner for this company, currently overseeing 2 pending office actions. This is a low concentration of work, as the 2 actions handled by this examiner represent only a small portion of the total pending actions. The involvement of 51 distinct examiners across the art units underscores the complexity of the company's ongoing patent prosecution efforts.

Written from this page's own data; every figure is computed from USPTO records and verified before publication.

Portfolio Summary

61
Total Pending OAs
34
Non-Final OAs
25
Final Rejections
2
Advisory / Quayle

Response Deadline Pressure

Based on the USPTO statutory response window for each pending office action. 24 of the docket's apps have a known mailing date; the rest are excluded from the tile counts.

10
Overdue
0
Due this week
7
Due this month
6
Due in next 60 days
1
Due later

Deadline Fire Line

Every pending office action with a known statutory deadline, placed on a days-until-due axis. Dots left of Today are overdue; the further right, the more runway. Cases that share a deadline window stack vertically. 24 of the docket's apps have a known mailing date.

-30dToday30d60d90d120d
Overdue (10)Due ≤ 30 days (7)Due ≤ 60 days (6)Due later (1)

Case Difficulty Mix

Difficulty is derived from the rejection statutes on the most recent pending office action. §101-driven and multi-statute cases are graded Hard; §112-only and obviousness-type double-patenting cases are graded Easy; everything else is Medium. "Unknown" means we have not yet parsed a statute for that office action.

38
Hard (62%)
19
Medium (31%)
4
Easy (7%)
0
Unknown (0%)

Rejection Statute Mix

BucketCases
§101 only2 (3%)
§101 + other19 (31%)
§103 only14 (23%)
§102 only4 (7%)
§112 only4 (7%)
Double-patenting + other1 (2%)
Multi-statute (no §101)17 (28%)

Industry Mix

How the docket's pending cases split across USPTO tech-center bands.

33
Life Sciences
54% of docket
2
Information Tech
3% of docket
0
Communications
0% of docket
4
Semiconductors
7% of docket
9
Mechanical / Eng
15% of docket
13
Business / Other
21% of docket

Time-on-OA Estimate

Manual office-action response work runs about 10 hours per case. The time-saved bands below show what IP Author's prosecution pipeline typically delivers — a conservative 20% on the low end, 35% in the middle, 50% on the high end.

610 h
Manual time on pending OAs
122 h
Time saved (low, 20%)
214 h
Time saved (mid, 35%)
5.3 wks
FTE-weeks freed (mid)

Top Examiners on this docket

ExaminerApps on this docketAllow rateInterview lift
SINES, BRIAN J 2 80.1% +5.2%
BORTOLI, JONATHAN 2 76.3% +41.2%
WHATLEY, BENJAMIN R 2 66.7% +68.5%
HRANEK, KAREN AMANDA 2 34.5% +39.9%
COUNTS, GARY W 2 58.9% +29.5%
LANKFORD JR, LEON B 2 70.0% +31.6%
CHIU, MAY LEUNG 2 44.8% +24.4%
MARCSISIN, ELLEN JEAN 2 34.5% +49.3%
NGUYEN, NAM P 2 54.8% +48.7%
BUTLER, SARAI E 1 88.1% +10.7%

Hard Cases (38)

Multi-statute / §101-driven matters, or cases in front of an examiner with an allow rate under 30%. The top 8 ordered by deadline are shown.

App #TitleExaminerDue in
17891458 IDENTIFICATION OF PATIENTS WITH ABNORMAL FRACTIONAL SHORTENING MARCSISIN, ELLEN JEAN 51d overdue
18636375 METHODS AND SYSTEMS OF SAMPLE QUALITY VERIFICATION SANGHERA, STEVEN G.S. 38d overdue
18352183 PROGNOSTIC VALUE OF BIOMARKERS IN PATIENTS WITH NON-SMALL CELL LUNG CANCER HAVING STABLE DISEASE SINES, BRIAN J 30d overdue
18556849 INFORMATION PROCESSING DEVICE FOR PROVIDING REFERENCE INFORMATION RELATING TO DIAGNOSIS OF THYROID DISEASE HRANEK, KAREN AMANDA 25d overdue
17162140 Use of Biomarkers in the Assessment of the Early Transition from Arterial Hypertension to Heart Failure MARCSISIN, ELLEN JEAN 19d overdue
18561621 sFRP4 AS BLOOD BIOMARKER FOR THE NON-INVASIVE DIAGNOSIS OF ADENOMYOSIS COUNTS, GARY W 8d overdue
17916251 A METHOD OF ASSESSING A FEMALE'S RISK OF HAVING PCOS AS WELL AS PRODUCTS AND USES RELATING THERETO VOLKOV, ALEXANDER ALEXANDROVIC 4d overdue
17907039 CORONA NUCLEOCAPSID ANTIGEN FOR USE IN ANTIBODY-IMMUNOASSAYS JOHANSEN, PETER N. 8d

Interview Candidates (17)

Cases in front of an examiner whose interview lift is 10 percentage points or more — i.e. interviewed cases historically resolve more favorably than non-interviewed ones. The top 8 ordered by deadline are shown.

App #TitleExaminerDue in
17891458 IDENTIFICATION OF PATIENTS WITH ABNORMAL FRACTIONAL SHORTENING MARCSISIN, ELLEN JEAN 51d overdue
18556849 INFORMATION PROCESSING DEVICE FOR PROVIDING REFERENCE INFORMATION RELATING TO DIAGNOSIS OF THYROID DISEASE HRANEK, KAREN AMANDA 25d overdue
17162140 Use of Biomarkers in the Assessment of the Early Transition from Arterial Hypertension to Heart Failure MARCSISIN, ELLEN JEAN 19d overdue
18561621 sFRP4 AS BLOOD BIOMARKER FOR THE NON-INVASIVE DIAGNOSIS OF ADENOMYOSIS COUNTS, GARY W 8d overdue
15892829 ALKALINE PRETREATMENT OF PARVOVIRUSES FOR IMMUNOASSAYS NGUYEN, NAM P 26d
17772959 SEPSIS MANAGEMENT COUNTS, GARY W 29d
17838568 PARTICLE-BASED IMMUNOASSAY USING A PEGYLATED ANALYTE-SPECIFIC BINDING AGENT NGUYEN, NAM P 34d
17814332 SAMPLE INPUT INTERFACE CHIU, MAY LEUNG 54d

Top Art Units

Art UnitApps
1678 5
1797 5
1677 4
3684 3
1796 3
2881 2
3651 2
1657 2
1758 2
1675 2

Pending Office Actions

App #TitleExaminerArt UnitStatutesStatusDue inAIFiled
19288563 METHOD FOR DETECTING AND REPORTING AN OPERATION ERROR IN AN IN-VITRO DIAGNOSTIC SYSTEM AND AN IN-VITRO DIAGNOSTIC SYSTEM BUTLER, SARAI E — §103§112Other Non-Final OA — Pending Aug 01, 2025
19004068 SAFE POINT PATTERN RODRIGUEZ, JOSEPH C 3662 §102§103§112 Non-Final OA — Pending Dec 27, 2024
19004137 DISTRIBUTION SYSTEM AND METHOD FOR DISTRIBUTING A PLURALITY OF CARRIERS TIGHE, BRENDAN P — §102 Non-Final OA — Pending Dec 27, 2024
18935834 METHOD AND LABORATORY SYSTEM FOR DETERMINING AT LEAST ONE CONTAINER INFORMATION ABOUT A LABORATORY SAMPLE CONTAINER SALEH, ZAID MUHAMMAD — §103 Non-Final OA — Pending Nov 04, 2024
18810797 METHOD FOR IMPROVING CROSS-FLOW FILTRATION AND CROSS-FLOW FILTRATION SYSTEM PATEL, PRANAV N — §103 Non-Final OA — Pending Aug 21, 2024
18719252 METHOD FOR CHARACTERIZATION OF A MASS SPECTROMETRY INSTRUMENT COMPRISING AT LEAST ONE MASS ANALYZING CELL WANG, JING 2881 §101§103§112 Non-Final OA — Pending Jun 12, 2024
18711999 AUTOMATIC ANALYZER SINES, BRIAN J — §102§103 Non-Final OA — Pending May 21, 2024
18669957 NOVEL BIOTIN-SPECIFIC MONOCLONAL ANTIBODY AND USE THEREOF HAQ, SHAFIQUL 1600 §103§112Other Non-Final OA — Pending May 21, 2024
18668368 METHOD AND SYSTEM FOR OPERATING A LABORATORY AUTOMATION SYSTEM BORTOLI, JONATHAN — §101 Non-Final OA — Pending May 20, 2024
18667208 OPTICAL SYSTEM FOR FOURIER PTYCHOGRAPHY HUANG, WEN 2872 §103 Final Rejection — Pending May 17, 2024
18649151 TRANSPORT DEVICE AND LABORATORY SAMPLE DISTRIBUTION SYSTEM JORGENSEN, ABBY A 3651 §103 Non-Final OA 3d overdue Pending Apr 29, 2024
18645358 ON-BOARD CONJUGATION NGUYEN, BAO THUY L — §102§103 Non-Final OA — Pending Apr 24, 2024
18642895 ADJUSTABLE ADAPTER AND LABORATORY SYSTEM WHATLEY, BENJAMIN R — §102§103§112 Non-Final OA — Pending Apr 23, 2024
18636375 METHODS AND SYSTEMS OF SAMPLE QUALITY VERIFICATION SANGHERA, STEVEN G.S. 3684 §101§103§112 Non-Final OA 38d overdue Pending Apr 16, 2024
18620273 LIGHT SOURCE FOR GENERATING ILLUMINATION LIGHT DOWNING, SAVANNAH STARR 2884 §103 Final Rejection 39d Pending Mar 28, 2024
18696634 FEDERATED LEARNING OF MEDICAL VALIDATION MODEL HRANEK, KAREN AMANDA 3684 §103 Non-Final OA — Pending Mar 28, 2024
18696730 MR-PROADM MARKER PANELS FOR EARLY DETECTION OF SEPSIS LEE, JAE W 1759 §101§103§112 Non-Final OA — Pending Mar 28, 2024
18692099 CENTERING HOLDER FOR CENTERING ONE SAMPLE TUBE WRIGHT, PATRICIA KATHRYN — §112 Non-Final OA — Pending Mar 14, 2024
18587217 COMPUTER-IMPLEMENTED METHOD WAQAS, SAAD A 2468 §102 Final Rejection 19d overdue Pending Feb 26, 2024
18433619 CHIMERIC IGG-FC-BINDING LIGAND POLYPEPTIDE AND USES THEREOF FOR IGG AFFINITY PURIFICATION SZPERKA, MICHAEL EDWARD — §103§112 Non-Final OA — Pending Feb 06, 2024
18579561 TRANSFER DEVICE FOR TRANSFERRING SAMPLE CONTAINERS IN A SAMPLE HANDLING SYSTEM WHATLEY, BENJAMIN R — §112 Non-Final OA — Pending Jan 16, 2024
18578369 AUTOMATIC ANALYZER AND GUIDANCE METHOD IN AUTOMATIC ANALYZER TURK, NEIL N 1798 §112 Non-Final OA — Pending Jan 11, 2024
18541476 METHOD FOR IMMUNOSENSING ON A LIPID LAYER DUNN, MCKENZIE A — §102§103DP Non-Final OA — Pending Dec 15, 2023
18541624 UNIVERSAL CALIBRATION FOR QUANTITATIVE MASS SPECTROMETRY ALABI, OYELEYE A — §101§102§103§112 Non-Final OA — Pending Dec 15, 2023
18566548 AN ANALYZER SYSTEM LI, LARRY 2881 §103 Final Rejection — Pending Dec 01, 2023
18561621 sFRP4 AS BLOOD BIOMARKER FOR THE NON-INVASIVE DIAGNOSIS OF ADENOMYOSIS COUNTS, GARY W 1678 §101§102§103§112 Non-Final OA 8d overdue Pending Nov 16, 2023
18558133 IL6 MARKER PANELS FOR EARLY DETECTION OF SEPSIS LANKFORD JR, LEON B 1657 §103 Non-Final OA — Pending Oct 30, 2023
18558150 ESM1 MARKER PANELS FOR EARLY DETECTION OF SEPSIS LANKFORD JR, LEON B 1657 §103 Non-Final OA — Pending Oct 30, 2023
18556849 INFORMATION PROCESSING DEVICE FOR PROVIDING REFERENCE INFORMATION RELATING TO DIAGNOSIS OF THYROID DISEASE HRANEK, KAREN AMANDA 3684 §101§103 Final Rejection 25d overdue Pending Oct 23, 2023
18353485 SAMPLE VESSEL CLOSURE METHOD, MOVABLE CAP GRIPPER AND SAMPLE VESSEL CLOSURE SYSTEM FOR AUTOMATICALLY CLOSING AN OPEN END OF A SAMPLE VESSEL WITH A CLOSURE CAP BORTOLI, JONATHAN 1797 §102 Non-Final OA — Pending Jul 17, 2023
18352183 PROGNOSTIC VALUE OF BIOMARKERS IN PATIENTS WITH NON-SMALL CELL LUNG CANCER HAVING STABLE DISEASE SINES, BRIAN J 1796 §101§102§103§112 Final Rejection 30d overdue Pending Jul 13, 2023
18339760 AUTOMATED CLINICAL DIAGNOSTIC SYSTEM AND METHOD WALLENHORST, MAUREEN 1797 §102§103§112 Non-Final OA — Pending Jun 22, 2023
18337018 LC-MS METHOD FOR DETECTING AND QUANTIFYING 11-OXYGENATED STEROIDS SODERQUIST, ARLEN 1797 §102§103§112 Final Rejection 21d Pending Jun 18, 2023
18333347 INTERFERENCE MONITORING FOR PROVIDING A VERIFIED ANALYTE MEASUREMENT HYUN, PAUL SANG HWA 1796 §101§102§103§112 Final Rejection 33d Pending Jun 12, 2023
18325328 SAMPLE CONTAINER HOLDING AND/OR TRANSPORTING DEVICE CHIU, MAY LEUNG 1797 §102§112 Non-Final OA — Pending May 30, 2023
18309985 TIMP1 AS A MARKER FOR CHOLANGIOCARCINOMA DENT, ALANA HARRIS 1643 §102 Final Rejection 20d Pending May 01, 2023
18299750 GRIPPING APPARATUS FOR GRIPPING SAMPLE CONTAINER LEEDS, DANIEL JEREMY 3731 §102§103 Final Rejection — Pending Apr 13, 2023
18028235 CIRCULATING TOTAL-NT-PROBNP (GLYCOSYLATED AND UNGLYCOSYLATED NT-PROBNP) AND ITS RATIO WITH NT-PROBNP (UNGLYCOSYLATED NT-PROBNP) IN THE ASSESSMENT OF ATRIAL FIBRILLATION FRITCHMAN, REBECCA M 1758 §101§103 Final Rejection — Pending Mar 24, 2023
18178595 INTELLIGENT USER GUIDANCE FOR LABORATORY ISSUE RESOLUTION ANDERSON, FOLASHADE 3623 §101 Final Rejection 36d Pending Mar 06, 2023
18021085 IGFBP7 FOR THE ASSESSMENT OF SILENT BRAIN INFARCTS AND COGNITIVE DECLINE WEIDNER, ADAM M 1675 §101§103§112 Non-Final OA — Pending Feb 13, 2023
18017073 GDF-15 FOR PREDICTING THE DISEASE SEVERITY OF A PATIENT WITH COVID-19 ZOU, NIANXIANG 1671 §101§103 Final Rejection 61d Pending Jan 19, 2023
18096477 LC COLUMN HANDLING USING WEIGHTED COUNTERS LEBRON, BENJAMIN L 1773 §101§102§103§112 Final Rejection — Pending Jan 12, 2023
17990903 REAGENT FOR MASS SPECTROMETRY ADAMS, MICHELLE 1797 §102§112 Non-Final OA — Pending Nov 21, 2022
17916251 A METHOD OF ASSESSING A FEMALE'S RISK OF HAVING PCOS AS WELL AS PRODUCTS AND USES RELATING THERETO VOLKOV, ALEXANDER ALEXANDROVIC 1677 §101§103§112 Final Rejection 4d overdue Pending Sep 30, 2022
17907039 CORONA NUCLEOCAPSID ANTIGEN FOR USE IN ANTIBODY-IMMUNOASSAYS JOHANSEN, PETER N. 1644 §103§112 Final Rejection 8d Pending Sep 22, 2022
17931993 CARRY-OVER MONITORING HILL, GRACELYN MARKHAM 1685 §101§103 Non-Final OA 13d Pending Sep 14, 2022
17893574 CLINICAL DECISION SUPPORT ON CLINICAL ANALYZER HIGGS, STELLA EUN 3681 §103 Final Rejection — Pending Aug 23, 2022
17891458 IDENTIFICATION OF PATIENTS WITH ABNORMAL FRACTIONAL SHORTENING MARCSISIN, ELLEN JEAN 1677 §101§103§112 Final Rejection 51d overdue Pending Aug 19, 2022
17814332 SAMPLE INPUT INTERFACE CHIU, MAY LEUNG 1758 §102§103§112 Final Rejection 54d Pending Jul 22, 2022
17838568 PARTICLE-BASED IMMUNOASSAY USING A PEGYLATED ANALYTE-SPECIFIC BINDING AGENT NGUYEN, NAM P 1678 §103 Final Rejection 34d Pending Jun 13, 2022
17664230 METHOD AND DISTRIBUTION SYSTEM TO MOVE CARRIERS ON A TRANSPORT PLANE CUMBESS, YOLANDA RENEE 3651 §102§103§112 Final Rejection 36d Pending May 20, 2022
17772959 SEPSIS MANAGEMENT COUNTS, GARY W 1678 §101§103 Non-Final OA 29d Pending Apr 28, 2022
17402808 LOCATION-BASED ACCESS CONTROL OF A MEDICAL ANALYZER MOHAMMADI, FAHIMEH M 2439 §103 Non-Final OA — Pending Aug 16, 2021
17444397 SAMPLE CONTAINER TRANSPORT SYSTEM LE, AUSTIN Q 1796 §103§112 Non-Final OA — Pending Aug 04, 2021
17360121 DETECTION OF BACTERIAL (MOLLICUTIES) CONTAMINATION BERTAGNA, ANGELA MARIE 1681 §101§103§112 Final Rejection 14d Pending Jun 28, 2021
17162140 Use of Biomarkers in the Assessment of the Early Transition from Arterial Hypertension to Heart Failure MARCSISIN, ELLEN JEAN 1677 §101§103§112 Final Rejection 19d overdue Pending Jan 29, 2021
17150504 METHODS OF IDENTIFYING AN INDIVIDUAL AS HAVING OR BEING AT RISK OF DEVELOPING AN AMYLOID-POSITIVE DEMENTIA BASED ON MARKER MOLECULES AND RELATED USES RAMADAN, OMAR 1678 §101§102§103§112 Final Rejection — Pending Jan 15, 2021
16825181 MULTIVALENT MONO- OR BISPECIFIC RECOMBINANT ANTIBODIES FOR ANALYTIC PURPOSE ESSEX, LAURA ANN 1675 §103 Non-Final OA — Pending Mar 20, 2020
16008281 FKBP DOMAIN WITH TRANSGLUTAMINASE RECOGNITION SITE DABKOWSKI, ERINNE R 1654 §112 Final Rejection 42d overdue Pending Jun 14, 2018
15965748 METHODS AND SYSTEMS FOR ANALYZING TISSUE QUALITY USING MID-INFRARED SPECTROSCOPY KIRWIN, STEFANIE JOHANNA 1677 §103Other Non-Final OA — Pending Apr 27, 2018
15892829 ALKALINE PRETREATMENT OF PARVOVIRUSES FOR IMMUNOASSAYS NGUYEN, NAM P 1678 §103§112 Non-Final OA 26d Pending Feb 09, 2018

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