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 .
DETAILED ACTION
1-21 and 23-31 are pending in the instant application.
Claims 1-2, 5-6, 8-10, 12, 14, 16-21, 26-29, and 31 are amended.
Claims 3, 7, 11, 13, 15, and 23-25 are cancelled.
Claims 1-2, 4-6, 8-10, 12, 14, 16-21 and 26-31 are examined herein.
Priority
The instant application claims benefit of foreign priority to GB2016492.7, filed on 16 October 2020, GB2111344.4, filed on 080 August 2021, and the benefit of priority to PCT/EP2021/078716, filed on 15 October 2021. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 16 October 2020.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 30 March 2026, 30 March 2026, and 30 June 2026, are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Response to Arguments
The amendment filed on 29 May 2026 has been entered.
In view of applicant amendment to claims 2, 6, 12, and 14, the objections of record are withdrawn.
In view of applicant amendment to claim 10 and cancellation of claims 11, 13, and 15, the 101 rejection of record is withdrawn.
In view of applicant amendment to claim, the 112(a)-enablement rejection of record is withdrawn.
In view of applicant amendment to claim 1, the 112(a)-written description rejection of record is withdrawn.
In view of applicant amendment to claims 1, 5, 10, 8, 16, and 29, the 112(b) rejections of record are withdrawn.
In view of applicant amendment to claim 1, the double patenting rejection of record is withdrawn.
In view of applicant amendment to claim 1, the 102(a)(1) rejection of record over Wood is withdrawn.
In view of applicant amendment to claim 10, the 102(a)(1) rejection of record over Lorenz is withdrawn.
In view of applicant amendment to claim 1, the 103 rejections of record are withdrawn.
In addition, new objections and rejections are necessitated by amendment (see below).
All rejections and objections not found below have been withdrawn.
NEW REJECTIONS FACILITATED BY AMENDMENT
Claim Objections
Claims 1, 5, and 10 are objected to because of the following informalities:
The claims list a group of tryptophans separated by commas and semi-colons. Either or should be used in the recited list.
Appropriate correction is required.
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) 1-2, 4-6, 8-10, 12, 14, 16-21 and 26-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sandyk (US5885876A; cited by Applicant on 1449 IDS) in view of Hanson et al. (Intractable Rare Dis Res. 2014;3(4):110–117).
Regarding claims 1-4, Sandyk teaches a method of treating neurological and mental disorders associated with deficient serotonin transmission, including autism (column 11, line 23), comprising administering a composition of a serotonin precursor, either L-tryptophan (L-TP) or L-5-hydroxytryprophan (5-HTP) (column 12, line 54).
Sandyk does not explicitly teach FMR1-mediated autism, but autism in general. FMR1-mediated autism is linked to Fragile X Syndrome (FXS).
Hanson focusses on FXS and teaches significant overlap between autism and FXS, as FXS is the leading monogenetic cause of autism (page 111, column 1). Hanson teaches serotonin dysregulation in patients with autism and FXS. Therefore it would be prima facie obvious to one skilled in the art that the generic teaching of autism associated with deficient serotonin transmission encompasses FMR1-mediated autism, as there is deficient serotonin transmission.
Regarding claims 5-6, Sandyk teaches the treatment of the autism comprising administering L-TP or 5-HTP.
Sandyk does not teach FXS.
Hanson, as stated above, teaches significant overlap between autism and FXS. Substitution of FXS for autism into the method taught by Sandyk would be obvious to the skilled artisan, as the disorders are related and both involve serotonin dysregulation. The skilled artisan would have a reasonable expectation of success in administering a serotonin precursor to treat the dysregulation.
Regarding claim 8, Sandyk teaches 5-HTP in a dose of 100-200 mg (column 18, line 29).
Regarding claim 9, Sandyk does not teach a dose of 100 mg three times a day. However, this would be routine optimization in the absence of criticality. See MPEP 2144.05.II.A. The skilled artisan would be motivated to decrease the dose and increase the frequency to keep the level of the compound steady within the patients blood levels, preventing large fluctuations and decreasing side effects.
Regarding claims 10 and 14, Sandyk teaches administering a stimulant of the serotonin receptor including ergoloid mesylates (column 13, line 45).
Regarding claim 12, Sandyk teaches 5-HTP.
Regarding claim 16, equiproportional preparation of dihydroergocornine, dihydroergocristine and dihydroergocryptine makes ergoloid mesylates, which is taught by Sandyk.
Regarding claim 17, Sandyk teaches a method of treating autism comprising administering L-TP or 5-HTP and an ergoloid mesylate.
Regarding claims 18-19, Sandyk teaches the treatment of the general autism, which encompasses the individualized diagnosis recited in the instant claims.
Regarding claim 20, the combination teaches FMR1-mediated autism
Regarding claim 21, Hanson teaches FXS.
Regarding claims 26-29, the combined teachings teach the combination of active pharmaceutical ingredients. It would be routine optimization to determine the most efficacious order of administration and dosing.
Regarding claim 30, Sandyk teaches administering a preparation containing L-TP or H-HTP. The skilled artisan would know the preparation would include a pharmaceutically acceptable carrier excipient, or diluent, to ensure the preparation is formulated to be orally bioavailable.
Regarding claim 31, Sandyk teaches further administering an SSRI (column 17, line 64).
Conclusion
1-2, 4-6, 8-10, 12, 14, 16-21 and 26-31 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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