Prosecution Insights
Last updated: April 19, 2026
Application No. 18/478,291

PSP94 AS BLOOD BIOMARKER FOR THE NON-INVASIVE DIAGNOSIS OF ENDOMETRIOSIS

Non-Final OA §102§103
Filed
Sep 29, 2023
Examiner
MUTREJA, JYOTI NAGPAUL
Art Unit
1798
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Roche Diagnostics Operations Inc.
OA Round
1 (Non-Final)
81%
Grant Probability
Favorable
1-2
OA Rounds
3y 0m
To Grant
85%
With Interview

Examiner Intelligence

Grants 81% — above average
81%
Career Allow Rate
740 granted / 913 resolved
+16.1% vs TC avg
Minimal +4% lift
Without
With
+3.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
32 currently pending
Career history
945
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
34.5%
-5.5% vs TC avg
§102
50.6%
+10.6% vs TC avg
§112
10.3%
-29.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 913 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. 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, 6, 8-9, 12, 14-21 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Domenyuk (US 2020/0376022) . Regarding claim 1, Domenyuk teaches detecting a protein a biological sample from a subject comprising (a) determining the amount or concentration of Prostatic secretory protein 94 (PSP94) in a sample of the patient, and (b) comparing the determined amount or concentration to a reference. (Refer to paragraph [0025]) (Refer to Table 1) (Refer to Table 4) Regarding claim 2, (a) determining the amount or concentration of Prostatic secretory protein 94 (PSP94) in a sample of the patient, and (b) comparing the determined amount or concentration to a reference. (Refer to paragraph [0025]) (Refer to Table 1) (Refer to Table 4) Regarding claim 3, the patient is being selected for drug- based therapy and / or selected for surgical treatment (laparoscopy). (Refer to paragraphs [0093-0094]) Regarding claim 6, an elevated amount or concentration of PSP94 in the sample of the patient is indicative of the presence of endometriosis in the patient. (Refer to paragraph [0025]) Regarding claim 8, the sample is a blood, serum, or plasma sample. (Refer to paragraph [0560]) Regarding claim 9, the assessment is performed independent of the rASRM staging. (Refer to paragraph [0025]) Regarding claim 12, endometriosis is selected from the group consisting of peritoneal endometriosis, endometrioma, deep infiltrating endometriosis, and adenomyosis. (Refer to paragraph [0028]) Regarding claim 14, determining the amount or concentration of CA-125 (mucin) . (Refer to Table 16) Regarding claim 15, calculating i)a ratio of the amount or concentration of PSP94 and the amount or concentration of CA- 125, or ii) a ratio of the amount or concentration of PSP94 and dysmenorrhea, or iii) a ratio of the amount or concentration of PSP94 and the amount or concentration of CA-125 and dysmenorrhea, or iv) a ratio of the amount or concentration of PSP94 and lower abdominal pain according to the VAS scale. (Refer to Table 17) Regarding claim 16, (a) receiving a value for the amount or concentration of a first biomarker in a sample of the subject, said first biomarker being PSP94; (b) optionally, receiving a value for the amount or concentration of a second biomarker in a sample of the subject, wherein said second biomarker is CA-125; (c) optionally, receiving a value for the amount or concentration of dysmenorrhea according to the VAS scale and/or lower abdominal pain according to the VAS scale: (d) comparing the values for the amounts or concentrations of steps (a) - (c) to references for said biomarkers and the amount or concentration of dysmenorrhea and/or calculating a score for assessing the subject with suspected endometriosis based on the amounts or concentrations of the biomarkers and the amount of dysmenorrhea; and (e) assessing said subject based on the comparison and/or the calculation made in step (d). It is reminded that applicants use the term “optionally” which is not required by the teachings of the prior art. Regarding claim 17, the amount of PSP94 is determined using monoclonal antibodies. (Refer to Table 17) Regarding claim 18, wh erein determining the amount of PSP94 in a sample of t he patient comprises the steps of i) incubating the sample of the patient with one or more antibodies specifically binding to PSP94, thereby generating a complex between the antibody and PSP94, and ii) quantifying the complex formed in step i), thereby quantifying the amount of PSP94 in the sample of the patient. (Refer to paragraphs [1048-1066]) Regarding claim 19, i) the sample is incubated with two antibodies, specifically binding to PSP94. (Refer to paragraphs [1048-1066]) Regarding claim 20, a sandwich is formed comprising a first antibody to PSP94, PSP94 (analyte) and the second antibody to PSP94, wherein the second antibody is detectably labeled. (Refer to paragraphs [1048-1066]) Regarding claim 21, w herein determining the amount of PSP94 in a sample of the patient comprises performing an immunoassay selected from the group consisting of enzyme linked immunosorbent assay (ELISA), enzyme immunoassay (EIA), radioimmunoassay (RIA), or immuno assays based on detection of luminescence, fluorescence, chemiluminescence, or electrochemiluminescence . (Refer to paragraph [1249]) Claim Rejections - 35 USC § 103 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 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) 5 , 7 , 10-11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Domenyuk . Refer to the teachings of Domenyuk above. Domenyuk is silent with respect to the teaching of the assessment of endometriosis is detected in stage IV per revised American Society for Reproductive Medicine ( rASRM ) classification system and Visual Analog Scale (VAS scale) and/or lower abdominal pain according to the Visual Analog Scale (VAS scale). Domenyuk does teaches comparing the presence of level of the transcript to a reference. Domenyuk also teaches various phenotypes to assess including pain. The American Society for Reproductive Medicine ( rASRM ) classification system and the VAS scale is conventionally known in the art in reproductive medicine . Therefore, it would have been obvious to use The American Society for Reproductive Medicine ( rASRM ) classification system and the VAS scale as a reference in determining the stage of endometriosis in the patient and the amount of pain the patient is in . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT JYOTI NAGPAUL whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-1273 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 9am to 5pm, EST . 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, FILLIN "SPE Name?" \* MERGEFORMAT Charles Capozzi can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-3638 . 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. /JYOTI Mutreja / Primary Examiner, Art Unit 1798
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Prosecution Timeline

Sep 29, 2023
Application Filed
Mar 19, 2026
Non-Final Rejection — §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
81%
Grant Probability
85%
With Interview (+3.7%)
3y 0m
Median Time to Grant
Low
PTA Risk
Based on 913 resolved cases by this examiner. Grant probability derived from career allow rate.

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