Prosecution Insights
Last updated: May 04, 2026
Application No. 18/188,943

Metabolic Markers of Attention Deficit Hyperactivity Disorder

Non-Final OA §112§DP
Filed
Mar 23, 2023
Priority
Feb 11, 2015 — provisional 62/115,101 +2 more
Examiner
SCHMITT, MICHAEL J
Art Unit
1629
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Laboratory Corporation Of America Holdings
OA Round
1 (Non-Final)
56%
Grant Probability
Moderate
1-2
OA Rounds
0m
Est. Remaining
78%
With Interview

Examiner Intelligence

Grants 56% of resolved cases
56%
Career Allowance Rate
363 granted / 642 resolved
-3.5% vs TC avg
Strong +22% interview lift
Without
With
+21.8%
Interview Lift
resolved cases with interview
Typical timeline
2y 10m
Avg Prosecution
35 currently pending
Career history
677
Total Applications
across all art units

Statute-Specific Performance

§101
4.0%
-36.0% vs TC avg
§103
36.8%
-3.2% vs TC avg
§102
16.5%
-23.5% vs TC avg
§112
18.6%
-21.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 642 resolved cases

Office Action

§112 §DP
DETAILED ACTION Claims 35-53 are pending. 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 Group I, claims 35-41 in the Reply filed on 3/11/2026, is acknowledged. Claims 42-53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the Reply. The requirement is still deemed proper and is therefore made FINAL. Claims 35-41 are present for Examination and the subject of the Office Action below. Priority The instant application filed 3/23/2023 is a Continuation of 16713903, filed 12/13/2019, now abandoned and having 1 RCE-type filing therein. 16713903 is a Continuation of 15019258, filed 2/9/2016, now U.S. Patent # 10525020. 15019258 Claims Priority from Provisional Application 62115101, filed 2/11/2015. Information Disclosure Statement The Information Disclosure Statement (IDS) submitted on 6/13/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statement is being considered by the Examiner. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claims 35-41 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The term “ blood sample ” in claim 35 is used by the claim to mean “ a blood sample clotted and centrifuged, to provide a plasma sample ,” or a “plasma sample,” as Applicant has not measured the level in whole blood, it is unclear what is actually meant by this term as the level measured by Applicant is in plasma. Applicant has never measure d the level in whole blood, as such it is unclear what level is to be used for “elevated” and this makes the claim relative to an unknown value and therefore indefinite. The relative nature of “ an elevated level of 3-Indoxyl Sulfate (3-IS) compared to a reference ” in claim 35 is also undefined as the reference level changes by age and by how the sample is prepared. Applicant in the Summary of the Specification points out this problem. In para [0031]-[0034] Applicant notes the level is different by age, as the pediatric population is 457 ± 228 ug/L, then states in adults it is 2.49 to 14uM (532 ug/L to 3000 ug/L), based on prior art Umino and Duranton (disclosed by Applicant). Moreover, Pretorius ( Pretorius et al. Clinica Chimica Acta 419 (2013) 122–126 ) notes the normal level of 0.7 to 6.3 um/L (150-1340 ug/L). Therefore the claim is not defined as the “ as having an elevated level of 3-Indoxyl Sulfate (3-IS) compared to a reference ,” does not have a clear definition as the reference is relative to who reports the value and other factors not in the claim. Applicant recites the phrase, “ wherein a blood sample from the subject has previously been identified as having an elevated level of 3-Indoxyl Sulfate (3-IS) compared to a reference. ” The claim is indefinite as “ previously been identified ” in comparison to an unknown reference doesn’t allow one to know what is actually being compared and what the comparison is being made to. This is complicated by “ previously been identified ,” as this language might indicate the level is no longer elevated or the level is a comparison to a later/newer sample in the same patient. Regardless it is unclear what the reference is, and in what time frame, and if the measurement is even relevant to the treatment of ADHD. As such this term makes the claim indefinite. To further this point, note dependent claims refer to different ages of the patients, all of which might have a different reference value, and the value not defined and as such is a comparison to an unknown, making the term “elevated” undefined. 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 35-41 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1-12 of U.S. Patent No. 10525020 in view of Van der Oord et al. “ Efficacy of methylphenidate, psychosocial treatments and their combination in school-aged children with ADHD: A meta-analysi s” Clinical Psychology Review 28 (2008) 783–800 . ‘ 020 teaches diagnosing ADHD in patients by measuring 3-Indoxyl Sulfate in the blood sample of a subject and comparing the level to a reference. The “higher” level indicates ADHD. ‘020 teaches younger patients as well, patients 5 or 3 years or less. ‘020 doesn’t teach treating the patients. Van der Oord teaches treating ADHD patients with methylphenidate . The instant claims are obvious as one would look to improve the lived of ADHD patients, these patients diagnosed by the method of ‘020. One would then provide standard care to the diagnosed patients to improve their lives. As such the instant claims are obvious in view of the prior art in combination with ‘020. Conclusion No claims allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT MICHAEL J SCHMITT whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-7047 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 8-6 MidDay Flex . 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 Jeffrey Lundgren can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-5541 . 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. /MICHAEL J SCHMITT/ Examiner, Art Unit 1629 /JEFFREY S LUNDGREN/ Supervisory Patent Examiner, Art Unit 1629
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Prosecution Timeline

Mar 23, 2023
Application Filed
Mar 31, 2026
Non-Final Rejection — §112, §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
56%
Grant Probability
78%
With Interview (+21.8%)
2y 10m (~0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 642 resolved cases by this examiner. Grant probability derived from career allowance rate.

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