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
2. Claims 34 – 53 are pending in this application. Applicant’s preliminary amendment, submitted April 24, 2024, is entered, wherein claims 34 – 53 are new and claims 1 – 33 are canceled.
Claims 34 – 53 are examined on the merits herein.
Priority
3. This application is a divisional application of 17/285,815, filed April 15, 2021, now issued as U.S. Patent No. 12,285,421, which is a national stage application of PCT/IB2019/058853, filed October 17, 2019, that claims benefit of foreign priority document IN201841039516, filed October 18, 2018.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 17/285,815, filed on April 15, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/25/2024, 05/23/2024, and 10/31/2024 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 47 – 49 are objected to because of the following informalities:
Claim 47, line 16, “,” should be inserted immediately after “behavior disorder”.
Claims 48 – 49, line 3, “,” should be inserted immediately after “administering step”.
Appropriate correction is required.
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 34 – 39, 41 – 44, 46, and 50 – 52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nirogi et al. (US2015/0283125A1).
a. Nirogi et al. teach the novel compounds of formula (I) and the pharmaceutically acceptable salt thereof. The compounds of formula (I) are useful in the treatment of various disorders that are related to 5-HT4 receptor (para. [0001]). The invention is related to use of a therapeutically effective amount of compound of formula (I) on a patient in need, to manufacture a medicament in the treatment of various disorders that are related to 5-HT4 receptor (para. [0013]; claim 10). The various disorders include Alzheimer’s disease and dementia (para. [0014]). In another aspect, the invention relates to pharmaceutical compositions containing a therapeutically effective amount of at least one compound of formula (I) in admixture with pharmaceutically acceptable excipient (para. [0015]). The pharmaceutical compositions may be formulated in a conventional manner for oral, intranasal, or parenteral administration (para. [0077]). The compound of formula (I) is 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt (para. [0022]). Nirogi et al. specifically disclose the claimed compound as Example 3, namely 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt. Nirogi et al. further disclose that Example 3 is administered to male Wistar rats (225±25 grams) in a brain penetration study at 10 mg/kg by oral gavage using reagent-grade water as vehicle, and at 5 mg/kg intravenously using sterile water for injection as vehicle in example (para. [0269], Example 52):
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Nirogi et al. further evaluate cognitive enhancing properties in Example 53, the object recognition task model, and Example 54, the radial arm maze model. In these assay examples, the “Example Number 3” corresponds to the compound prepared in synthetic Example 3, which is 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt. Nirogi et al. report that Example 3 is active in the object recognition task at 3 mg/kg p.o. and reversed scopolamine-induced amnesia in the radial arm maze at 1 – 3 mg/kg p.o. (para. [0273 – 0279]):
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Therefore, Nirogi et al. teach administration of the claimed compound and improvement of memory and/or cognitive performance after administration.
Regarding claims 38 and 43, Nirogi et al. disclose that Example 3 is administered as a single dose in the rodent brain penetration study. As the compound is administered only once on the day of dosing, Nirogi et al. teach administration of the claimed compound one time per day.
Regarding claims 39 and 44, Nirogi et al. disclose that Example 3 is formulated in a vehicle for administration in the rodent brain penetration study. Specifically, Nirogi et al. disclose that Example 3 is formulated in reagent grade water for oral gavage administration and in sterile water for injection for intravenous bolus administration to male Wistar rats. The reagent grade water and sterile water for injection function as formulation vehicles or excipients for administering the active compound. Thus, Nirogi et al. teach that the claimed compound is present in a composition further comprising an excipient.
Regarding claim 41, Nirogi et al. disclose administration of Example 3 to male Wistar rats having a body weight of 225 g. For the oral dose, 10 mg/kg administered to a 0.225 kg rat corresponds to 2.25 mg of Example 3. For the intravenous dose, 5 mg/kg administered to a 0.225 kg rat corresponds to 1.125 mg of Example 3. Both amounts fall within the claimed range of about 1 mg to about 2000 mg.
For these reasons above, Nirogi et al. anticipate the claimed invention.
Claims 34 – 37, 45 – 47, and 50 – 53 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nirogi et al. (WO2016/027277A1; hereinafter ‘277A1).
b. ‘277A1 teaches that 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt is a promising pharmaceutical agent, which is potent, selective and orally bioavailable 5-HT4 receptor partial agonist intended for both disease modifying and symptomatic treatment of Alzheimer’s disease (page 1, lines 23 – 26). In addition to the pro-cognitive effects, the compound also demonstrates dose dependent antidepressant like effects in the mouse forced swim test (page 2, lines 1 – 3). 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt has completed preclinical studies and is ready to enter human clinical trials (page 2, lines 6 – 8).
For these reasons above, ‘277A1 anticipates the claimed invention.
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:
i. Determining the scope and contents of the prior art.
ii. Ascertaining the differences between the prior art and the claims at issue.
iii. Resolving the level of ordinary skill in the pertinent art.
iv. 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 34, 39 – 40, 50, and 52 – 53 are rejected under 35 U.S.C. 103 as being unpatentable over Nirogi et al. (US2015/0283125A1) in view of Abrantes et al. (Journal of Pharmaceutical Sciences, 2016, Vol. 105, Issue 7, page 2019 – 2026, Reference included with PTO-892).
c. Nirogi et al. teach the novel compounds of formula (I) and the pharmaceutically acceptable salt thereof. The compounds of formula (I) are useful in the treatment of various disorders that are related to 5-HT4 receptor (para. [0001]). The invention is related to use of a therapeutically effective amount of compound of formula (I) on a patient in need, to manufacture a medicament in the treatment of various disorders that are related to 5-HT4 receptor (para. [0013]; claim 10). The various disorders include Alzheimer’s disease and dementia (para. [0014]). In another aspect, the invention relates to pharmaceutical compositions containing a therapeutically effective amount of at least one compound of formula (I) in admixture with pharmaceutically acceptable excipient (para. [0015]). The pharmaceutical compositions may be formulated in a conventional manner for oral, intranasal, or parenteral administration (para. [0077]). The compound of formula (I) is 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt (para. [0022]). Nirogi et al. specifically disclose the claimed compound as Example 3, namely 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt. Nirogi et al. teach a rodent pharmacokinetic study, wherein male Wister rats of 225 g body weight are dosed with the compound of formula (I) at 10 mg/kg orally one time for one day (para. [0266]). Thus, Nirogi et al. teach a method of treating behavioral and psychological symptoms of dementia comprising the step of administering to a patient in need thereof, a therapeutically effective amount of 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt, wherein the 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt is in a composition further comprising a pharmaceutical acceptable excipient, which reads on the limitations of claims 34 and 39.
However, Nirogi et al. do not teach that the 5-HT4 receptor agonist is 1 to 90% by weight of the composition. Nirogi et al. do not explicitly teach the patient is a human.
Abrantes et al. teaches that a medicine consists of 2 fundamental parts: the active pharmaceutical ingredient and the excipient (Abstract). Excipients constitute about 90% of the total volume of a medicine (page 2020, Left Col., para. 5).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to formulate the pharmaceutical composition comprising 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt as taught by Nirogi et al. with conventional pharmaceutically acceptable excipients in an amount that provides a workable oral or parenteral pharmaceutical composition, including an API within about 1% to 90% by weight, because the relative amount of API and excipient is a routine formulation parameter selected to provide the desired dosage strength and route of administration and Abrantes et al. teach the conventional pharmaceutical formulation principle that the API is combined with excipients, with excipients commonly making up a substantial portion of the finished medicine. One would have been motivated to consider the conventional pharmaceutical formulation principle disclosed by Abrantes et al. when formulating a pharmaceutical composition because Nirogi et al. already teach that the claimed active compound may be formulated as a pharmaceutical composition in admixture with a pharmaceutically acceptable excipient and Abrantes et al. provides general formulation guidance that medicines ordinarily include both an API and excipients in a certain amount. Based on the conventional pharmaceutical formulation principle, one would have performed routine experimentation to discover the best amount of 5-HT4 receptor agonist and excipient in the composition. One of ordinary skill in the art would have had a reasonable expectation of success to formulate the pharmaceutical composition comprising 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt as taught by Nirogi et al. with conventional pharmaceutically acceptable excipients in an amount that provides a workable oral or parenteral pharmaceutical composition, including an API within about 1% to 90% by weight, because determining the relative amount of API and excipient in a dosage form is a routine formulation parameter selected based on desired dose strength and route of administration. Therefore, selecting an API within the broad claimed range of about 1% to about 90% by weight would have involved no more than routine optimization of a known pharmaceutical composition.
Regarding claim 53, Nirogi et al. teach administering the compound to a “patient in need thereof” for the treatment of Alzheimer’s disease and dementia. Nirogi et al. further teach that the disclosed compounds are useful in the treatment of clinical conditions including Alzheimer’s disease and dementia (claim 19). In addition, example 50 of Nirogi et al. determines EC50 values for the disclosed compounds using a stable CHO cell line expressing recombinant human 5-HT4 receptor (para. [0264]). Thus, example 50 demonstrates that the disclosed compounds, including the claimed compound, are active at the human 5-HT4 receptor. Because Nirogi et al. is directed to pharmaceutical treatment of dementia and Alzheimer’s disease in a patient in need thereof, and further evaluates the disclosed compounds at the human 5-HT4 receptor, Nirogi et al. reasonably discloses administration to human patient.
Claims 34, 36, and 48 – 49 are rejected under 35 U.S.C. 103 as being unpatentable over Nirogi et al. (US2015/0283125A1) in view of Barlow et al. (US7678808B2).
d. Nirogi et al. teach the novel compounds of formula (I) and the pharmaceutically acceptable salt thereof. The compounds of formula (I) are useful in the treatment of various disorders that are related to 5-HT4 receptor (para. [0001]). The invention is related to use of a therapeutically effective amount of compound of formula (I) on a patient in need, to manufacture a medicament in the treatment of various disorders that are related to 5-HT4 receptor (para. [0013]; claim 10). The various disorders include Alzheimer’s disease and dementia (para. [0014]). In another aspect, the invention relates to pharmaceutical compositions containing a therapeutically effective amount of at least one compound of formula (I) in admixture with pharmaceutically acceptable excipient (para. [0015]). The pharmaceutical compositions may be formulated in a conventional manner for oral, intranasal, or parenteral administration (para. [0077]). The compound of formula (I) is 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt (para. [0022]). Nirogi et al. further teach that the therapeutically effective amount is an amount of the compound that treat the particular disease, condition, or disorder; eliminates one or more symptoms of the particular disease, condition or disorder; and/or delays the onset of one or more symptoms of the particular disease, condition, or disorder (para. [0074]). Thus, Nirogi et al. teach a method of treating behavioral and psychological symptoms of dementia comprising the step of administering to a patient in need thereof, a therapeutically effective amount of 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt, wherein the 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt is in a composition further comprising a pharmaceutical acceptable excipient, and wherein the behavioral and psychological symptoms is decreased after the administration, which read on the limitations of claims 34, 36, and 48 – 49.
However, Nirogi et al. do not teach that the method of treating behavioral and psychological symptoms, wherein the symptom is aggression, and wherein the aggression is decreased after the administration step.
Barlow et al. disclose use of a 5HTR agent for treating diseases and conditions of central and peripheral nervous system by stimulating or increasing neurogenesis (Abstract). In some embodiments, a 5HTR4 agent is used in stimulating or increasing neurogenesis (Col. 4, lines 62 – 63). The disclosure includes a method of treating a mood disorder in such a subject or patient (Col. 19, line 67; Col. 20, line 1). The mood disorder include aggression (Col. 20, line 15). Thus, Barlow et al. teach the use of 5HTR4 agent to treat mood disorder, such as aggression.
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to apply the method of Nirogi et al. to treat aggression in view of Barlow et al. as the behavioral and psychological symptom of dementia because Nirogi et al. teach administering a therapeutically effective amount of 5-HT4 receptor agonist compound, including the claimed oxalate salt, to a patient in need thereof for treatment of disorders related to 5-HT4 receptor, such as Alzheimer’s disease and dementia and Barlow et al. teach the use of a 5-HT4 receptor agent for treating diseases and conditions of the central or peripheral nervous system by stimulating or increasing neurogenesis, wherein the diseases or conditions may be mood disorder that includes aggression. Thus, Barlow et al. provide a reason to use 1 5-HT4 receptor agent to treat aggression. One of ordinary skill in the art would have been motivated to apply the method of Nirogi et al. to treat aggression in view of Barlow et al. as the behavioral and psychological symptom of dementia because both references are directed to 5-HT4 receptor agents for treating central nervous system-related disorders in patient. One of ordinary skill in the art would have had a reasonable expectation of success to apply the method of Nirogi et al. to decrease aggression in view of Barlow et al. as the behavioral and psychological symptom of dementia because Nirogi et al. teach use of the claimed 5-HT4 receptor agents for dementia and define a therapeutically effective amount as an amount that eliminates one or more symptoms of the disease or order and Barlow et al. teach that aggression is treatable using 5-HT4 receptor agents.
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 34 – 36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 10 – 11 of U.S. Patent No. 9363335B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘335B2 anticipates the claimed invention.
a. ‘335B2 claims a method of treating dementia, attention deficit hyperactivity disorder, and schizophrenia, comprising the step of administering to a patient in need thereof an effective amount of a compound of general formula (I) or pharmaceutically acceptable salt thereof, wherein the compound of general formula (I) is Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate (claims 1, 3, and 10 – 11).
For these reasons above, ‘335B2 anticipates the claimed invention.
Claims 34 – 39, 41 – 44, 46, and 50 – 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 10 – 11 of U.S. Patent No. 9363335B2 in view of Nirogi et al. (US2015/0283125A1).
b. ‘335B2 claims a method of treating dementia comprising the step of administering to a patient in need thereof an effective amount of a compound of general formula (I) or pharmaceutically acceptable salt thereof, wherein the compound of general formula (I) is Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate (claims 1, 3, and 10 – 11).
However, ‘335B2 does not teach that the claimed compound is administered to the patient by an oral route. ‘335B2 does not teach the claimed compound is administered to the patient one to three times per day. ‘335B2 does not teach that the claimed compound is in a composition further comprising a pharmaceutically acceptable excipient. ‘335B2 does not teach the claimed compound is present in the composition in an amount of about 1 mg to about 2000 mg. ‘335B2 does not teach the behavioral and psychological symptoms of dementia is the symptoms of Alzheimer’s disease. ‘335B2 does not explicitly teach that the patient is a human.
Nirogi et al. teach the novel compounds of formula (I) and the pharmaceutically acceptable salt thereof. The compounds of formula (I) are useful in the treatment of various disorders that are related to 5-HT4 receptor (para. [0001]). The invention is related to use of a therapeutically effective amount of compound of formula (I) on a patient in need, to manufacture a medicament in the treatment of various disorders that are related to 5-HT4 receptor (para. [0013]; claim 10). The various disorders include Alzheimer’s disease and dementia (para. [0014]). In another aspect, the invention relates to pharmaceutical compositions containing a therapeutically effective amount of at least one compound of formula (I) in admixture with pharmaceutically acceptable excipient (para. [0015]). The pharmaceutical compositions may be formulated in a conventional manner for oral, intranasal, or parenteral administration (para. [0077]). The compound of formula (I) is 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt (para. [0022]). Nirogi et al. specifically disclose the claimed compound as Example 3, namely 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt. Nirogi et al. further disclose that Example 3 is administered to male Wistar rats (225±25 grams) in a brain penetration study at 10 mg/kg by oral gavage using reagent-grade water as vehicle, and at 5 mg/kg intravenously using sterile water for injection as vehicle in example (para. [0269], Example 52):
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Nirogi et al. further evaluate cognitive enhancing properties in Example 53, the object recognition task model, and Example 54, the radial arm maze model. In these assay examples, the “Example Number 3” corresponds to the compound prepared in synthetic Example 3, which is 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt. Nirogi et al. report that Example 3 is active in the object recognition task at 3 mg/kg p.o. and reversed scopolamine-induced amnesia in the radial arm maze at 1 – 3 mg/kg p.o. (para. [0273 – 0279]):
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Therefore, Nirogi et al. teach administration of the claimed compound and improvement of memory and/or cognitive performance after administration.
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to apply the method of ‘335B2 to treat the symptoms of Alzheimer’s disease in view of Nirogi et al. because ‘335B2 teach administering a therapeutically effective amount of 5-HT4 receptor agonist compound, including the claimed oxalate salt, to a patient in need thereof for treatment of disorders related to 5-HT4 receptor, such as dementia and Nirogi et al. teach the use of the same compound for treating Alzheimer’s disease. Thus, Nirogi et al. provide a reason to use the same compound to treat Alzheimer’s disease. One of ordinary skill in the art would have been motivated to apply the method of ‘335B2 to treat Alzheimer’s disease in view of Nirogi et al. because both references are directed to the same compound for treating central nervous system-related disorders in patient. One of ordinary skill in the art would have had a reasonable expectation of success to apply the method of ‘335B2 to treat Alzheimer’s disease in view of Nirogi et al. because ‘335B2 teaches the use of the claimed 5-HT4 receptor agents for dementia and Nirogi et al. teach that Alzheimer’s disease is treatable using the same claimed compound
Regarding claims 38 and 43, Nirogi et al. disclose that Example 3 is administered as a single dose in the rodent brain penetration study. As the compound is administered only once on the day of dosing, Nirogi et al. teach administration of the claimed compound one time per day.
Regarding claims 39 and 44, Nirogi et al. disclose that Example 3 is formulated in a vehicle for administration in the rodent brain penetration study. Specifically, Nirogi et al. disclose that Example 3 is formulated in reagent grade water for oral gavage administration and in sterile water for injection for intravenous bolus administration to male Wistar rats. The reagent grade water and sterile water for injection function as formulation vehicles or excipients for administering the active compound. Thus, Nirogi et al. teach that the claimed compound is present in a composition further comprising an excipient.
Regarding claim 41, Nirogi et al. disclose administration of Example 3 to male Wistar rats having a body weight of 225 g. For the oral dose, 10 mg/kg administered to a 0.225 kg rat corresponds to 2.25 mg of Example 3. For the intravenous dose, 5 mg/kg administered to a 0.225 kg rat corresponds to 1.125 mg of Example 3. Both amounts fall within the claimed range of about 1 mg to about 2000 mg.
Regarding claim 53, Nirogi et al. teach administering the compound to a “patient in need thereof” for the treatment of Alzheimer’s disease and dementia. Nirogi et al. further teach that the disclosed compounds are useful in the treatment of clinical conditions including Alzheimer’s disease and dementia (claim 19). In addition, example 50 of Nirogi et al. determines EC50 values for the disclosed compounds using a stable CHO cell line expressing recombinant human 5-HT4 receptor (para. [0264]). Thus, example 50 demonstrates that the disclosed compounds, including the claimed compound, are active at the human 5-HT4 receptor. Because Nirogi et al. is directed to pharmaceutical treatment of dementia and Alzheimer’s disease in a patient in need thereof, and further evaluates the disclosed compounds at the human 5-HT4 receptor, Nirogi et al. reasonably discloses administration to human patient.
Claim 40 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 10 – 11 of U.S. Patent No. 9363335B2 in view of Nirogi et al. (US2015/0283125A1) as applied to claims 34 – 39, 41 – 44, 46, and 50 – 53 above, and further in view of Abrantes et al. (Journal of Pharmaceutical Sciences, 2016, Vol. 105, Issue 7, page 2019 – 2026, Reference included with PTO-892).
c. Regarding claim 40, ‘335B2 and Nirogi et al. teach the limitations discussed above.
However, ‘335B2 and Nirogi et al. do not teach that the 5-HT4 receptor agonist is 1 to 90% by weight of the composition.
Abrantes et al. teaches that a medicine consists of 2 fundamental parts: the active pharmaceutical ingredient and the excipient (Abstract). Excipients constitute about 90% of the total volume of a medicine (page 2020, Left Col., para. 5).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to formulate the pharmaceutical composition comprising 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt as taught by ‘335B2 with conventional pharmaceutically acceptable excipients in an amount that provides a workable oral or parenteral pharmaceutical composition, including an API within about 1% to 90% by weight, in view of Abrantes et al. because the relative amount of API and excipient is a routine formulation parameter selected to provide the desired dosage strength and route of administration and Abrantes et al. teach the conventional pharmaceutical formulation principle that the API is combined with excipients, with excipients commonly making up a substantial portion of the finished medicine. One would have been motivated to consider the conventional pharmaceutical formulation principle disclosed by Abrantes et al. when formulating a pharmaceutical composition because Nirogi et al. already teach that the claimed active compound may be formulated as a pharmaceutical composition in admixture with a pharmaceutically acceptable excipient and Abrantes et al. provides general formulation guidance that medicines ordinarily include both an API and excipients in a certain amount. Based on the conventional pharmaceutical formulation principle, one would have performed routine experimentation to discover the best amount of 5-HT4 receptor agonist and excipient in the composition. One of ordinary skill in the art would have had a reasonable expectation of success to formulate the pharmaceutical composition comprising 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt as taught by ‘335B2 and Nirogi et al. with conventional pharmaceutically acceptable excipients in an amount that provides a workable oral or parenteral pharmaceutical composition, including an API within about 1% to 90% by weight, because determining the relative amount of API and excipient in a dosage form is a routine formulation parameter selected based on desired dose strength and route of administration. Therefore, selecting an API within the broad claimed range of about 1% to about 90% by weight would have involved no more than routine optimization of a known pharmaceutical composition.
Claims 34 – 36, 39, 44, and 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 2, 5 – 10, and 13 of U.S. Patent No. 9079894B2.Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘894B2 anticipates the claimed invention.
d. ‘894B2 teaches a compound of general formula (I) or a pharmaceutically acceptable salt thereof (claim 1), wherein the a compound of general formula (I) is Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate (claims 2, 7 – 9, and 13). ‘894B2 teaches a pharmaceutical composition comprising said compound and pharmaceutically acceptable excipients (claims 5 and 10). The pharmaceutical composition is used for the treatment of clinical condition, such as Alzheimer’s disease and dementia (claim 6).
For these reasons above, ‘894B2 anticipates the claimed invention.
Claims 34 – 39, 41 – 44, 46, and 50 – 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 2, 5 – 10, and 13 of U.S. Patent No. 9079894B2 in view of Nirogi et al. (US2015/0283125A1).
e. ‘894B2 teaches a compound of general formula (I) or a pharmaceutically acceptable salt thereof (claim 1), wherein the a compound of general formula (I) is Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate (claims 2, 7 – 9, and 13). ‘894B2 teaches a pharmaceutical composition comprising said compound and pharmaceutically acceptable excipients (claims 5 and 10). The pharmaceutical composition is used for the treatment of clinical condition, such as schizophrenia (claim 6).
However, ‘894B2 does not teach that the claimed compound is administered to the patient by an oral route. ‘894B2 does not teach the claimed compound is administered to the patient one to three times per day. ‘894B2 does not teach that the claimed compound is in a composition further comprising a pharmaceutically acceptable excipient. ‘894B2 does not teach the claimed compound is present in the composition in an amount of about 1 mg to about 2000 mg. ‘894B2 does not teach the behavioral and psychological symptoms of dementia is the symptoms of Alzheimer’s disease. ‘894B2 does not explicitly teach that the patient is a human.
Nirogi et al. teach the novel compounds of formula (I) and the pharmaceutically acceptable salt thereof. The compounds of formula (I) are useful in the treatment of various disorders that are related to 5-HT4 receptor (para. [0001]). The invention is related to use of a therapeutically effective amount of compound of formula (I) on a patient in need, to manufacture a medicament in the treatment of various disorders that are related to 5-HT4 receptor (para. [0013]; claim 10). The various disorders include Alzheimer’s disease and dementia (para. [0014]). In another aspect, the invention relates to pharmaceutical compositions containing a therapeutically effective amount of at least one compound of formula (I) in admixture with pharmaceutically acceptable excipient (para. [0015]). The pharmaceutical compositions may be formulated in a conventional manner for oral, intranasal, or parenteral administration (para. [0077]). The compound of formula (I) is 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt (para. [0022]). Nirogi et al. specifically disclose the claimed compound as Example 3, namely 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt. Nirogi et al. further disclose that Example 3 is administered to male Wistar rats (225±25 grams) in a brain penetration study at 10 mg/kg by oral gavage using reagent-grade water as vehicle, and at 5 mg/kg intravenously using sterile water for injection as vehicle in example (para. [0269], Example 52):
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Nirogi et al. further evaluate cognitive enhancing properties in Example 53, the object recognition task model, and Example 54, the radial arm maze model. In these assay examples, the “Example Number 3” corresponds to the compound prepared in synthetic Example 3, which is 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt. Nirogi et al. report that Example 3 is active in the object recognition task at 3 mg/kg p.o. and reversed scopolamine-induced amnesia in the radial arm maze at 1 – 3 mg/kg p.o. (para. [0273 – 0279]):
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Therefore, Nirogi et al. teach administration of the claimed compound and improvement of memory and/or cognitive performance after administration.
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to apply the method of ‘894B2 to treat the symptoms of Alzheimer’s disease in view of Nirogi et al. because ‘894B2 teach administering a therapeutically effective amount of 5-HT4 receptor agonist compound, including the claimed oxalate salt, to a patient in need thereof for treatment of disorders related to 5-HT4 receptor, such as dementia and Nirogi et al. teach the use of the same compound for treating Alzheimer’s disease. Thus, Nirogi et al. provide a reason to use the same compound to treat Alzheimer’s disease. One of ordinary skill in the art would have been motivated to apply the method of ‘894B2 to treat Alzheimer’s disease in view of Nirogi et al. because both references are directed to the same compound for treating central nervous system-related disorders in patient. One of ordinary skill in the art would have had a reasonable expectation of success to apply the method of ‘894B2 to treat Alzheimer’s disease in view of Nirogi et al. because ‘894B2 teaches the use of the claimed 5-HT4 receptor agents for dementia and Nirogi et al. teach that Alzheimer’s disease is treatable using the same claimed compound
Regarding claims 38 and 43, Nirogi et al. disclose that Example 3 is administered as a single dose in the rodent brain penetration study. As the compound is administered only once on the day of dosing, Nirogi et al. teach administration of the claimed compound one time per day.
Regarding claims 39 and 44, Nirogi et al. disclose that Example 3 is formulated in a vehicle for administration in the rodent brain penetration study. Specifically, Nirogi et al. disclose that Example 3 is formulated in reagent grade water for oral gavage administration and in sterile water for injection for intravenous bolus administration to male Wistar rats. The reagent grade water and sterile water for injection function as formulation vehicles or excipients for administering the active compound. Thus, Nirogi et al. teach that the claimed compound is present in a composition further comprising an excipient.
Regarding claim 41, Nirogi et al. disclose administration of Example 3 to male Wistar rats having a body weight of 225 g. For the oral dose, 10 mg/kg administered to a 0.225 kg rat corresponds to 2.25 mg of Example 3. For the intravenous dose, 5 mg/kg administered to a 0.225 kg rat corresponds to 1.125 mg of Example 3. Both amounts fall within the claimed range of about 1 mg to about 2000 mg.
Regarding claim 53, Nirogi et al. teach administering the compound to a “patient in need thereof” for the treatment of Alzheimer’s disease and dementia. Nirogi et al. further teach that the disclosed compounds are useful in the treatment of clinical conditions including Alzheimer’s disease and dementia (claim 19). In addition, example 50 of Nirogi et al. determines EC50 values for the disclosed compounds using a stable CHO cell line expressing recombinant human 5-HT4 receptor (para. [0264]). Thus, example 50 demonstrates that the disclosed compounds, including the claimed compound, are active at the human 5-HT4 receptor. Because Nirogi et al. is directed to pharmaceutical treatment of dementia and Alzheimer’s disease in a patient in need thereof, and further evaluates the disclosed compounds at the human 5-HT4 receptor, Nirogi et al. reasonably discloses administration to human patient.
Claim 40 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 2, 5 – 10, and 13 of U.S. Patent No. 9079894B2 in view of Nirogi et al. (US2015/0283125A1) as applied to claims 34 – 39, 41 – 44, 46, and 50 – 53 above, and further in view of Abrantes et al. (Journal of Pharmaceutical Sciences, 2016, Vol. 105, Issue 7, page 2019 – 2026, Reference included with PTO-892).
f. Regarding claim 40, ‘894B2 and Nirogi et al. teach the limitations discussed above.
However, ‘894B2 and Nirogi et al. do not teach that the 5-HT4 receptor agonist is 1 to 90% by weight of the composition.
Abrantes et al. teaches that a medicine consists of 2 fundamental parts: the active pharmaceutical ingredient and the excipient (Abstract). Excipients constitute about 90% of the total volume of a medicine (page 2020, Left Col., para. 5).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to formulate the pharmaceutical composition comprising 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt as taught by ‘894B2 with conventional pharmaceutically acceptable excipients in an amount that provides a workable oral or parenteral pharmaceutical composition, including an API within about 1% to 90% by weight, in view of Abrantes et al. because the relative amount of API and excipient is a routine formulation parameter selected to provide the desired dosage strength and route of administration and Abrantes et al. teach the conventional pharmaceutical formulation principle that the API is combined with excipients, with excipients commonly making up a substantial portion of the finished medicine. One would have been motivated to consider the conventional pharmaceutical formulation principle disclosed by Abrantes et al. when formulating a pharmaceutical composition because both ‘894B2 and Nirogi et al. already teach that the claimed active compound may be formulated as a pharmaceutical composition in admixture with a pharmaceutically acceptable excipient and Abrantes et al. provides general formulation guidance that medicines ordinarily include both an API and excipients in a certain amount. Based on the conventional pharmaceutical formulation principle, one would have performed routine experimentation to discover the best amount of 5-HT4 receptor agonist and excipient in the composition. One of ordinary skill in the art would have had a reasonable expectation of success to formulate the pharmaceutical composition comprising 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt as taught by ‘894B2 and Nirogi et al. with conventional pharmaceutically acceptable excipients in an amount that provides a workable oral or parenteral pharmaceutical composition, including an API within about 1% to 90% by weight, because determining the relative amount of API and excipient in a dosage form is a routine formulation parameter selected based on desired dose strength and route of administration. Therefore, selecting an API within the broad claimed range of about 1% to about 90% by weight would have involved no more than routine optimization of a known pharmaceutical composition.
Claims 34 – 44, 46, and 50 – 53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34 – 44 and 48 – 51 of copending Application No. 18/645,116 in view of Nirogi et al. (US2015/0283125A1) with evidence provided by Stetka (Scientific American, 2015, Reference included with PTO-892).
g. Regarding claims 34 – 51, ‘116 teaches a method of treating a cognitive deficit associated with schizophrenia comprising the step of administering to a patient in need thereof, a therapeutically effective amount of a 5-HT4 receptor agonist, wherein the 5-HT4 receptor agonist is Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole or a pharmaceutically acceptable salt thereof (claim 34). ‘116 teaches that the pharmaceutically acceptable salt is Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate (claims 35 – 36). The 5-HT4 receptor agonist is administered to the patient by an oral route one to three times per day (claims 37 – 38 and 42 – 43). ‘116 teaches that the 5-HT4 receptor agonist is in a composition further comprising a pharmaceutically acceptable excipient (claims 39 and 44), wherein the 5-HT4 receptor agonist is 1 to 90% by weight of the composition (claim 40). The 5-HT4 receptor agonist is present in the composition in an amount of about 1 mg to about 2000 mg (claim 41). The patient to be treated is an animal, wherein the animal is a mammal, wherein the mammal is a human (claims 48 – 51).
However, ‘116 does not teach a method of treating behavioral and psychological symptoms of dementia.
Nirogi et al. teach the novel compounds of formula (I) and the pharmaceutically acceptable salts thereof. The compounds of formula (I) are useful in the treatment of various disorders that are related to 5-HT4 receptor (Abstract). Nirogi et al. disclose a method of treating cognitive disorders, dementia, Alzheimer’s disease, attention deficit hyperactivity disorder, schizophrenia, and pain, wherein the method comprising the step of administering to a patient in need thereof an effective amount of a compound of formula (I) or pharmaceutically acceptable salt thereof (claim 10), wherein the compound of formula (I) is 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt (claim 11). Nirogi et al. disclose a pharmaceutical composition containing a therapeutically effective amount of the compound of formula (I) or the pharmaceutically acceptable salt thereof in admixture with pharmaceutical acceptable excipient (para. [0015]). The pharmaceutical composition may be formulated for oral or parenteral (para. [0077]). Nirogi et al. teach a rodent pharmacokinetic study, wherein male Wister rats of 225 g body weight are dosed with the compound of formula (I) at 10 mg/kg orally one time for one day (para. [0266]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of treating a cognitive deficit associated with schizophrenia as taught by ‘116 to a method of treating cognitive disorders, dementia, Alzheimer’s disease, attention deficit hyperactivity disorder, schizophrenia, and pain in view of Nirogi et al. because Nirogi et al. teach the claimed 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt and teach that the claimed compound may be used to treat schizophrenia. One would have been motivated to modify the method of treating a cognitive deficit associated with schizophrenia as taught by ‘116 to a method of treating cognitive disorders, dementia, Alzheimer’s disease, attention deficit hyperactivity disorder, schizophrenia, and pain in view of Nirogi et al. because Nirogi et al. teach the same claimed compound and disclose that the claimed compound may be used to treat dementia and Alzheimer’s disease. One of ordinary skill in the art would have had a reasonable expectation of success to modify the method of treating cognitive deficit associated with schizophrenia as taught by ‘116 to a method of treating cognitive disorders, dementia, Alzheimer’s disease, attention deficit hyperactivity disorder, schizophrenia, and pain in view of Nirogi et al. because it is known in the art that the claimed compound may be used to treat dementia and Alzheimer’s disease.
Regarding claim 41, Nirogi et al. disclose administration of Example 3 to male Wistar rats having a body weight of 225 g. For the oral dose, 10 mg/kg administered to a 0.225 kg rat corresponds to 2.25 mg of Example 3. For the intravenous dose, 5 mg/kg administered to a 0.225 kg rat corresponds to 1.125 mg of Example 3. Both amounts fall within the claimed range of about 1 mg to about 2000 mg.
Regarding claims 45 – 47, Nirogi et al. teach that cognitive enhancing properties of the compound of formula (I) are evaluated in object recognition task model and radial arm maze model:
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Nirogi et al. disclose that the object recognition task included a long-term memory test and reports that Example 3, corresponding to the claimed 1-Isopropyl-3-{5-[1-(3-methoxypropyl)piperidin-4-yl]-[1,3,4]oxadiazol-2-yl}-1H-indazole oxalate salt, is active in the object recognition model. Nirogi et al. further disclose that Example 3 reversed scopolamine-induced amnesia at 1 – 3 mg/kg p.o. in the radial arm maze (para. [0273 – 0279]). Therefore, Nirogi et al. teach that administration of the claimed compound improves cognitive function and memory, thereby anticipating claims 45 – 47.
Regarding claim 53, Nirogi et al. teach administering the compound to a “patient in need thereof” for the treatment of Alzheimer’s disease and dementia. Nirogi et al. further teach that the disclosed compounds are useful in the treatment of clinical conditions including Alzheimer’s disease and dementia (claim 19). In addition, example 50 of Nirogi et al. determines EC50 values for the disclosed compounds using a stable CHO cell line expressing recombinant human 5-HT4 receptor (para. [0264]). Thus, example 50 demonstrates that the disclosed compounds, including the claimed compound, are active at the human 5-HT4 receptor. Because Nirogi et al. is directed to pharmaceutical treatment of dementia and Alzheimer’s disease in a patient in need thereof, and further evaluates the disclosed compounds at the human 5-HT4 receptor, Nirogi et al. reasonably discloses administration to human patient.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is found to be allowable.
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/H.Y.L./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
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