DETAILED ACTION
Claims 1, 9-13, 21-28 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 .
Priority
The instant application filed 06/03/2024 is a Continuation of 16884652, filed 05/27/2020, now U.S. Patent # 12029712 and having 1 RCE-type filing therein. 16884652 is a Continuation of 16459916, filed 07/02/2019, now U.S. Patent # 10668036. 16459916 is a Continuation of PCT/US2018/062263, filed 11/21/2018. PCT/US2018/062263 Claims Priority from Provisional Application 62755157, filed 11/02/2018. PCT/US2018/062263 Claims Priority from Provisional Application 62636427, filed 02/28/2018. PCT/US2018/062263 Claims Priority from Provisional Application 62636081, filed 02/27/2018. PCT/US2018/062263 Claims Priority from Provisional Application 62590109, filed 11/22/2017.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 12/30/2024, 7/31/2025, and 3/3/2026, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statements are being considered by the Examiner.
Background Information
The compound instantly claimed, “Compound 100” is known in the Chemical Abstracts as STN RN 103292-62-2 published in the database July 19, 1986.
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Therefore this is a known compound.
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.
Claims 1, 9-12, and 21-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reider et al. J. Org. Chem., Vol. 52, No. 15, 1987 p.3326-3334.
The instant claims are directed towards a pharmaceutical composition comprising Compound 100:
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wherein each position designated specifically as deuterium has at least 50.1 % incorporation of deuterium; or a pharmaceutically acceptable salt thereof; and a pharmaceutically acceptable carrier.
The claim is broad, as it does not require any specific amount of Compound 100 or any specific amount of carrier.
Reider teaches the chemical synthesis of Compound 100, which Reider calls it by the chemical name (R)-Serine-2-d. Reider isolates 19.7g of the compound with >99.8 chiral purity and >95% incorporation of deuterium.
Reider takes and NMR spectrum of the isolated material by dissolving a small amount in 18% DCl/D2O, this sample meets all the limitation of claims 1, 9-12, and 21-23. As acidic water would meet the limitation of a pharmaceutically acceptable carrier.
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.
Claims 1, 9-12, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Kantrowitz et al. Schizophrenia Research, August 2010, 125-130; Heresco-Levy (“Heresco-Levy I”) US 2017/0326137 A1 published November 16, 2017; Tsai et al. (“Tsai 145”) US 2002/0035145 A1 published March 21, 2002; Heresco-Levy et al. (“Heresco-Levy II”) US 2014/0187597 A1 published July 3, 2014; Tsai et al. BIOL. PSYCHIATRY 1998, 44:1081–1089; Blake et al. Journal of Pharmaceutical Sciences March 1975 367 (in the IDS); Concert Pharma et al. Internet Citation (in the IDS), 2007; and Reider et al. J. Org. Chem., Vol. 52, No. 15, 1987 p.3326-3334.
The instant claims are generally directed towards a pharmaceutical composition comprising Compound 100:
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wherein each position designated specifically as deuterium has at least 50.1 % incorporation of deuterium; or a pharmaceutically acceptable salt thereof; and a pharmaceutically acceptable carrier. The later dependent claims require a higher incorporation of deuterium, and require 98% enantiopurity. These limitations were discussed and are met by the synthetic method of Reider.
Instant claims 13 requires an amount of Compound 100 to be 0.1 g to 60 g of the composition, and claims 24-28 require 1g, 2g, 3g, and 5g of the compound in the composition.
The first four references (over Kantrowitz, Heresco-Levy I, Tsai 145, Heresco-Levy II) establish the treatment of all the diseases and disorders with D-serine, a non-deuterated form. As such these references establish the fact that D-serine is used to treat disease by increasing NMDA function as instantly claimed. The difference between the instant and the prior art is using deuterated analogs of D-serine for those diseases, using 2-2H-serine (instantly claimed compound 100) in place of non-deuterated D-serine.
Tsai specifically teaches using D-serine in combination with antipsychitics for the treatment of schizophrenia. Thirty-one Taiwanese schizophrenic patients enrolled in a 6-week double-blind, placebo-controlled trial of D-serine (30 mg/kg/day), which was added to their stable antipsychotic regimens. 30 mpk is roughly 2.1g per day in a 70 kg person. Of these, 28 completed the trial. Measures of clinical efficacy, side effects, and serum levels of amino acids and D-serine were determined every other week. Wisconsin Card Sorting Test (WCST) was performed at the beginning and end of the trial. Results: Patients who received D-serine treatment revealed significant improvements in their positive, negative, and cognitive symptoms as well as some performance in WCST. D-serine levels at week 4 and 6 significantly predicted the improvements. D-serine was well tolerated and no significant side effects were noted.
Blake and Concert teach that deuterated drugs are well established in the art, as are deuterated amino acids. Blake provides guidance for deuteration and shows that amino acids are deuterated. See page 381 for discussion of amino acids.
Concert explains why one would deuterate drugs. Stating that deuteration provides potential for improved safety, better tolerability, and enhanced efficacy. Stating that Concert compounds are based on drugs with known efficacy and safety that address clinically validated targets. This allows CONCERT to rapidly create novel, differentiated compounds with substantially reduced R&D risk, time and expense.
Reider teaches 2-2H-(D-serine) (instantly claimed compound 100) as a pure compound capable of being used in compositions.
A person of ordinary skill in the art would have a reasonable expectation of success in substituting known compound, including 2-2H-(D-serine) for known D-serine in the treatment of schizophrenia known to be treated with D-serine itself. It is common to use deuterated compounds to improve PK/PD properties, and serine only has 6 positions to choose from, moreover one would look to start with compounds already known in the art. Such as using 2-2H-D-serine (instantly claimed compound 100). As such the instant invention was prima facie obvious at the time of filing.
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 1, 9-13, 21-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-9 of U.S. Patent No. 10,668,036. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘036 patent calls for giving 1-4g per day of Compound 100 to a patient, which would require a pharmaceutical composition.
Claims 1, 9-13, 21-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 12,029,712. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘712 patent calls for giving 1-10 g per day of Compound 100 to a patient, which would require a pharmaceutical composition.
Conclusion
No claims allowed.
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.
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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.
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/MICHAEL J SCHMITT/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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