DETAILED ACTION
Claims 35-53 were pending and claims 42-53 were withdrawn. Claims 35 and 42 have been amended per the Reply of 7/20/2026.
Claims 35-53 are pending and claims 42-53 stand withdraw.
Claims 35-41 are the Subject of the Office Action below.
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 .
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..
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 applicant 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 relative nature of “an elevated level of 3-Indoxyl Sulfate (3-IS) compared to a reference level of normal subjects without ADHD” 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 of normal subjects without ADHD” does not have a clear definition as the reference is relative to who reports the value and other factors not in the claim. The value in the art is not clearly defined, so referring to “a reference level of normal subjects without ADHD” is not defined.
Applicant recites the phrase, “wherein a plasma sample from the subject was, prior to said administering, identified as having an elevated level of 3-Indoxyl Sulfate (3-IS) compared to a reference level of normal subjects without ADHD.” The claim is indefinite as “prior to administration” 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 “prior to administration,” 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. Moreover prior to which administration, Applicant has not shown if the level will drop after the first administration and/or if the patient is naïve to treatment. Given one would be administered the drugs over a long period of treatment, the “prior” step does not clearly define the level to be referenced. 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.
Response to Arguments: Applicant amended the claims to overcome the rejection. The amendments did not define the patient, the timeframe, or the reference level and are therefore not persuasive.
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 as 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-analysis” 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.
Response to Arguments: Applicant stated they submitted a TD, no TD has been submitted.
Conclusion
No claims allowed.
THIS ACTION IS MADE FINAL. 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 MICHAEL J SCHMITT whose telephone number is (571)270-7047. The examiner can normally be reached 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, Jeffrey Lundgren can be reached at 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
Prosecution Insights