Prosecution Insights
Last updated: April 19, 2026
Application No. 18/485,566

INDIRECT HOMOGENEOUS MOBILITY SHIFT ASSAYS FOR THE DETECTION OF BIOLOGICS IN PATIENT SAMPLES

Non-Final OA §DP
Filed
Oct 12, 2023
Examiner
HAWTHORNE, OPHELIA ALTHEA
Art Unit
3786
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Prometheus Laboratories Inc.
OA Round
1 (Non-Final)
72%
Grant Probability
Favorable
1-2
OA Rounds
3y 2m
To Grant
99%
With Interview

Examiner Intelligence

Grants 72% — above average
72%
Career Allow Rate
913 granted / 1273 resolved
+1.7% vs TC avg
Strong +30% interview lift
Without
With
+30.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
49 currently pending
Career history
1322
Total Applications
across all art units

Statute-Specific Performance

§101
5.3%
-34.7% vs TC avg
§103
38.9%
-1.1% vs TC avg
§102
25.0%
-15.0% vs TC avg
§112
22.5%
-17.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1273 resolved cases

Office Action

§DP
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. Specification The amendment to the specification were received on 10/12/2023. These amendments are acknowledged and accepted by the Office. Double Patenting 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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer . Claims 36-54 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1- 11 and 14-18 of U.S. Patent No. (11,846,642 B2) . Although the conflicting claims are not identical, they are not patentably distinct from each other because the application claims are a broader recitation of the invention than that of the patented application. Claim 36 of the instant application recite: A detection method, comprising: contacting a sample from a subject that has been administered a biologic with a polypeptide, wherein the sample comprises the biologic, and wherein the polypeptide is unlabeled; indirectly detecting binding of the polypeptide to the biologic in the sample by measuring a form of the biologic used to contact the polypeptide in vitro; and determining a presence or an amount of the biologic in the sample based on the binding of the polypeptide to the form of the biologic that is detected in the sample. Claim 1 of U.S. Patent No. (11,846,642 B2 ) recite: A detection method, comprising: (a) providing a sample from a subject that has been administered a first biologic, wherein the sample comprises the first biologic; (b) contacting the sample with a polypeptide, wherein the polypeptide is unlabeled, isolated, and soluble; (c) contacting the polypeptide in vitro with a second biologic; (d) indirectly detecting binding of the polypeptide to the first biologic in the sample by measuring a form of the second biologic in (c), wherein the binding of the polypeptide to the second biologic in the sample that is detected determines a presence or an amount of the first biologic in the sample; and (e) detecting a presence or an amount of an autoantibody to the first biologic in the sample. Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between claim 36 of the current application and claim 1 of patent (‘ 642 ) lies in the fact that the patented claims include many more elements and is thus much more specific. Thus, the invention of claim 1 of patent (‘ 642 ) is in effect a “species” of the “generic” invention of current application claim 36 . It has been held that the generic invention is “anticipated” by the “species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 36 of the current application is anticipated by claim 1 of patent (‘ 642 ), it is not patentably distinct from claim 1 of patent (‘ 642 ). All of the limitations of claim 3 7 of the instant application can be found in claim 1 of U.S. patent No. (‘ 642 ). All of the limitations of claim 3 8 of the instant application can be found in claim 1 of U.S. patent No. (‘ 642 ). All of the limitations of claim 39 of the instant application can be found in claim 2 of U.S. patent No. (‘ 642 ). All of the limitations of claim 40 of the instant application can be found in claim 3 of U.S. patent No. (‘ 642 ). All of the limitations of claim 41 of the instant application can be found in claim 4 of U.S. patent No. (‘ 642 ). All of the limitations of claim 42 of the instant application can be found in claim 1 of U.S. patent No. (‘ 642 ). All of the limitations of claim 43 of the instant application can be found in claim 5 of U.S. patent No. (‘ 642 ). All of the limitations of claim 44 of the instant application can be found in claim 6 of U.S. patent No. (‘ 642 ). All of the limitations of claim 45 of the instant application can be found in claim 7 of U.S. patent No. (‘ 642 ). All of the limitations of claim 4 6 of the instant application can be found in claim 8 of U.S. patent No. (‘ 642 ). All of the limitations of claim 4 7 of the instant application can be found in claim 9 of U.S. patent No. (‘ 642 ). All of the limitations of claim 4 8 of the instant application can be found in claim 10 of U.S. patent No. (‘ 642 ). All of the limitations of claim 4 9 of the instant application can be found in claim 11 of U.S. patent No. (‘ 642 ). All of the limitations of claim 5 0 of the instant application can be found in claim 14 of U.S. patent No. (‘ 642 ). All of the limitations of claim 5 1 of the instant application can be found in claim 15 of U.S. patent No. (‘ 642 ). All of the limitations of claim 5 2 of the instant application can be found in claim 16 of U.S. patent No. (‘ 642 ). All of the limitations of claim 5 3 of the instant application can be found in claim 1 7 of U.S. patent No. (‘ 642 ). All of the limitations of claim 5 4 of the instant application can be found in claim 18 of U.S. patent No. (‘ 642 ). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT OPHELIA ALTHEA HAWTHORNE whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3860 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 8:00 AM-5:00 PM, 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 Alireza Nia can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 5712703076 . 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. /OPHELIA A HAWTHORNE/ Primary Examiner, Art Unit 3786
Read full office action

Prosecution Timeline

Oct 12, 2023
Application Filed
Mar 26, 2026
Non-Final Rejection — §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

1-2
Expected OA Rounds
72%
Grant Probability
99%
With Interview (+30.3%)
3y 2m
Median Time to Grant
Low
PTA Risk
Based on 1273 resolved cases by this examiner. Grant probability derived from career allow rate.

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