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
Filing Receipt and Priority
The filing receipt mailed 09/15/2022 states the instant application is a continuation of PCT/US2021/012869, filed 01/10/2021 which claims benefit of provisional applications 62/959,534, 62/980,053, and 63/022,484 filed 01/10/2020, 02/21/2020, and 05/09/2020 respectively.
The instant application finds support in the 62/959,534 provisional. Therefore the effective filing date is 01/10/2020.
Information Disclosure Statement
The information disclosure statements submitted on 07/08/2022, 05/23/2023, 07/18/2023, 01/29/2024, 04/10/2025, and 09/09/2025 have been considered.
Response to Amendments
The amendments made to the claims 09/09/2025 have been entered.
Restriction/Species Election
The election of the following group and species is acknowledged.
Applicant has elected without traverse Group I, claims 35, 37, 41-46, 48, 49, 51, and 55-62.
Applicant has elected the following species.
-a compound of formula II shown below,
-a method for treating,
-narcolepsy.
Compound of Formula II
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Applicant states that the elected species read on claims 35, 37, 44-46, 48, 49, 51, and 60-62.
Claims 41-43, 55, and 57-59 are withdrawn from further consideration as being drawn to non-elected species.
Claim 51 is drawn to methods of claim 35 wherein the subject has Prader-Willi Syndrome.
Claims 60-62 are drawn to methods of claim 35 wherein the subject has hypnagogic hallucinations, hypnopompic hallucinations, or sleep paralysis respectively.
Prader-Willi syndrome is a distinct condition from narcolepsy. Hypnagogic and hypnopompic hallucinations are noted as symptoms of narcolepsy. Likewise, sleep paralysis is also a symptom of narcolepsy. However, the above symptoms are not always present in narcolepsy. Therefore, claims 51 and 60-62 are withdrawn from further prosecution being drawn to unelected species.
Applicant may traverse and provide evidence that hypnagogic and/or hypnopompic hallucinations are consistently present in narcolepsy. Similar, applicant may traverse the withdrawal of sleep paralysis by providing evidence that sleep paralysis is consistently present in narcolepsy.
At examiner’s discretion, examination has been broaden to include cataplexy claim 56).
Status of claims
Claims under examination are claims 35, 37, 44-46, and 48-49, and 56.
Rejections
Claim Rejections - 35 USC § 103
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.
Claim(s) 35, 37, 44-46, 48-49 and 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naganuma (Neurobiology of Disease 120, 2018, 12-20) in view of Guzzo (US9650378, published 2017), Abad (Nature and Science of Sleep, 2017:9 39-57) and Barateau (CNS Drugs, 2016, 30:369-379).
Independent claim 35 is drawn to a method of treating narcolepsy comprising administering the following compound of formula II or deuterated forms (non-elected species)
Compound of formula II
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Dependent claim 37 is drawn to the compound of formula II (non-deuterated), above.
Dependent claims 44-46 are drawn to effects of administering the compound above. Specifically, claim 44 is drawn to a method of administering wherein the administration achieves a steady state plasma concentration at about 5 to 4000 ng/m, claim 45 is drawn to embodiments wherein the steady state is achieved after 3 to 5 times the elimination half-life or between 7 to 14 days after periodic administration, and claim 46 is drawn to embodiments wherein plasma concentration of claim 44 is the trough level or trough concentration (lowest concentration) is reached before a second administration or is determined from blood samples taken between about 2 hours and 24 hours after the last dose or administration.
Dependent claims 48-49 are drawn to specific narcolepsy types which are narcolepsy type 1 and type 2.
Regarding claim 35 and 56, Naganuma teaches methods of administering an MCH receptor antagonist (SNAP 94847) (abstract). Naganuma on p. 14, sec. 3.2 Experiment 2: blockade of MCH signaling in a mouse model of narcolepsy teaches administration of the MCHR1 antagonist SNAP 94847. Naganuma in sec. 4.4 states “SNAP 94847 dramatically reduced baseline amounts of cataplexy and SLREMS in OC-KO mice. In the 6 h after vehicle, the OX-KO mice displayed moderate amounts of cataplexy and SLREMS, but SNAP 94847 reduced cataplexy by 80% and SLREMs by 75%.” Naganuma on p. 19, sec. 6 states “As the present study was designed to primarily evaluate the role of MCH neurons in narcolepsy, we injected the MCHR1 antagonist, SNAP 94847 only in mouse model of narcolepsy, and our results convincingly show that this drug strongly attenuates narcolepsy symptoms.” Additionally, Naganuma in sec. , states “MCH antagonism strongly reduces both cataplexy and abnormal REM sleep transitions. These results suggest a causal role for MCH neurons in narcolepsy.”
Naganuma therefore shows that MCH antagonism is an effective method of treating symptoms of narcolepsy and/or cataplexy. However, Naganuma does not teach the specific compound of formula II. This is addressed by the combination of Guzzo.
Regarding claim 35 and 37, Guzzo in col. 275 teaches compound 49, shown below, which is the hydrochloride salt of the instant compound.
Guzzo, compound 49
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Guzzo in col. 254, l. 31-34 states “By methods as described above, the compounds listed in Table 1 were synthesized and tested for biological activity. All compounds in Table 1 exhibited Kf of less than or equal to 3.5 μM in MCH1 binding assays I and II”. Additionally, Guzzo in col. 1, l. 15-20 states “The invention relates to human melanin-concentrating hormone (MCH1) receptor-selective antagonists.” This statement indicates that the compounds in Guzzo are MCH antagonists.
Regarding claims 44-46 which, as stated above, are drawn to conditions that are a result of administering the compound of Formula II, the claim limitations are essentially properties of the compound. While the art is silent to the specific properties, said properties are inherent to the compound which is disclosed in the art. The MPEP section 2112, subsection I states:
““[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.”
Therefore, the limitations of claims 44-46 do not make the claims patentable as the compound was disclosed in the prior art.
Naganuma and Guzzo do not explicitly discuss Narcolepsy type 1 or narcolepsy type 2. This is addressed by Abad and Barateau.
Regarding claims 48 and 49, Abad on p. 40, sec. Diagnosis, classification, and epidemiology states “The international Classification of Sleep Disorders (ICSD-3) classifies narcolepsy into Type 1 (narcolepsy with cataplexy) and Type 2 (narcolepsy without cataplexy).” Abad continues “Narcolepsy Type 1 criteria require cataplexy plus either 1) two sleep-onset REM periods (SOREMPS) on multiple latency test (MSLT) or a SOREMP on nocturnal polysomnogram (PSG) plus one SOREMP on MSLT or 2) cerebrospinal (CSF) hypocretin-1 (hert-1) concentration ≤ 110 pg/mL or <1/3 of mean values obtained in normal subjects with same standardized assay in addition to EDS.
Barateau teaches broadly to treatment options for narcolepsy (title). Barateau on p. 373, sec. Treatment options for Narcolepsy Type 2 states “To our knowledge, no pharmacological study has focused exclusively on patients with NT2; however, most studies conducted in narcolepsy included patients with and without cataplexy. Current medications and guidelines to treat EDS and symptoms associated with REM sleep dysregulation or disturbed nocturnal sleep in NT2 should be the same as for NT1.”
Naganuma teaches that inhibition of MCH in an effective method of treating symptoms of narcolepsy and cataplexy. Guzzo teaches compounds that are taught to be strong MCH antagonists. Abad teaches that narcolepsy type 1 and type 2 are distinct conditions, but Barateau teaches that treatment of both conditions is the same. Therefore, one of ordinary skill in the art would have found it prima facie obvious at the time of the effective filing date to have combined Naganuma with Guzzo, Abad, and Barateau to arrive at he instant claims with a reasonable assumption of success. One of ordinary skill in the art would have found motivation to make the combination as the Naganuma teaches MCH antagonism is effective for treating symptoms of narcolepsy and cataplexy.
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, 37, 44-46, 48-49, and 56 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 and 34-37 of U.S. Patent No. 9,650,378 in view of Naganuma (Neurobiology of Disease 120, 2018, 12-20) in view of Abad (Nature and Science of Sleep, 2017:9 39-57) and Barateau (CNS Drugs, 2016, 30:369-379).
The reference claims are drawn to compounds of a formula I shown below.
Guzzo Formula I
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Reference claim 21 claims the following compound.
Guzzo Claim 21 compound
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Guzzo in col. 313 states that the compounds of Formula I are “compounds that bind strongly to MCH1”. Naganuma teaches a method of treating narcolepsy that involves administration of an MCH antagonist. One of ordinary skill in the art would find it obvious to modify the method of Naganuma by using the compound of Guzzo as Guzzo teaches that its compounds “strongly bind to MCH” and are “melanin-concentrating hormone (MCH1) receptor-selective antagonists”.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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/L.G./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624