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 .
Election/Restrictions
Applicant’s election without traverse of Group II (claims 19-20 and new claims 21-35) in the reply filed on 11/20/25 is acknowledged.
The restriction requirement is still deemed proper and is therefore made FINAL.
Claims 1-18 were cancelled.
Claims 19-35 are pending and included in the prosecution.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 02/23/24; 08/28/24; 09/19/24; 05/21/25; and 12/02/25 and the Third-Party Submission filed on 07/10/24 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statements. Please see the attached copies of PTO-1449.
Claim Objections
Claim 23 is objected to because of the following informalities: In claim 23, line 2, the term “comprising” should be replaced by “comprises.” Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 22, 25, and 26 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 pre-AIA the applicant regards as the invention.
Claim 22 recites the limitation “wherein the amount of magnesium sulfate is an amount to provide a concentration of magnesium in the blood for a period of time, and said administering ibogaine or salt thereof comprises administering during the period of time.” The concentration of magnesium in the blood is a natural result after magnesium sulfate is administered to a patient. It is unclear what concentrations or time periods are covered by claim 22.
Claims 25 and 26 recite the limitation "wherein the amount of ibogaine or salt thereof …" in line 1. Claims 25 and 26 are dependent on claim 19. Claim 19, line 4, recites “a cardioprotective agent in an amount effective to …” but does not recite any amount of ibogaine. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 22 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 22 is dependent on claim 21 but does not further limit claim 21. Claim 22 recites the limitation “wherein the amount of magnesium sulfate is an amount to provide a concentration of magnesium in the blood for a period of time, and said administering ibogaine or salt thereof comprises administering during the period of time.” The concentration of magnesium in the blood is a natural result after magnesium sulfate is administered to a patient, and claim 22 does not recite any specific concentration. Therefore, claim 22 does not further limit claim 21. Regarding the administration of ibogaine or salt thereof, claim 22 is ultimately dependent on claim 19, and claim 19 recites the administration of ibogaine or a salt thereof along with the administration of a salt of magnesium. Since no time periods for administering ibogaine or a salt thereof and salt of magnesium are recited in claims 19, 21, or 22, claim 22 does not further limit the preceding claims.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Notice for all US Patent Applications filed on or after March 16, 2013
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 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.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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 19-27, 29, 31, and 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Olney (US 5,629,327) in view of Friedhoff (US 9,561,233) and Caron et al. (Pharmacotherapy, 23(3), pp. 296-300, 2003 – “Caron”).
Instant claim 19 is drawn to a method for treating a neuropsychiatric disorder of the brain, comprising:
administering to a subject with a neuropsychiatric disorder of the brain a cardioprotective agent in an amount effective to achieve a physiologic effect to reduce risk associated with drug-induced prolonged QT interval, wherein the cardioprotective agent is a salt of magnesium; and
administering ibogaine or a salt thereof.
Olney discloses that ibogaine can be used as a safe NMDA antagonist at relatively high dosages (including dosages high enough to cause hallucinations), to reduce or prevent excitotoxic brain damage due to stroke, cardiac arrest, trauma or other forms of neuronal injury or degeneration, without causing the neurotoxic side effects caused by other NMDA antagonist drugs (Abstract). Olney teaches that “… excessive activity at NMDA receptors can also aggravate neuronal damage caused by trauma (mechanical injury) to the brain or spinal cord … Many trauma victims suffer from a dangerous and potentially lethal increase in intracranial pressure … Elevated intracranial pressure is a major cause of morbidity and mortality in CNS trauma victims, and ibogaine, as an NMDA antagonist, is potentially useful in reducing intracranial pressures following such crises” (Col. 11, lines 26-38). Oral administration is disclosed (Col. 14, lines 51-57). Non-toxic and pharmacologically acceptable salts of ibogaine (Col. 14, lines 10-16), including pharmaceutically acceptable acid addition salts such as hydrochloric acid (Col. 14, lines 20-32) are disclosed. The preferred dosage of ibogaine will usually lie within the range of from about 5 to about 100 mg/kg per day if taken orally (¶ bridging Col. 15 and Col. 16), which is calculated to be about 350 mg to about 7000 mg for a 70 kg person.
Olney does not expressly teach administering a cardioprotective agent in an amount effective to achieve a physiologic effect to reduce risk associated with drug-induced prolonged QT interval, wherein the cardioprotective agent is a salt of magnesium.
Friedhoff teaches methods of treating pain in patients comprising treating patients with ibogaine (Abstract). Friedhoff teaches that it has been discovered that use of ibogaine imparts a dose dependent prolongation of the treated patient’s QT interval, rendering higher dosing of ibogaine unacceptable (Col. 2, lines 17-19). Friedhoff teaches pre-screening patients before treatment with ibogaine or a pharmaceutically acceptable salt thereof and monitoring of patients (e.g., under clinical or medical supervision) during ibogaine or a pharmaceutically acceptable salt thereof during treatment to ensure that QT interval is not prolonged beyond a certain value (Col. 39, lines 24-30). Friedhoff teaches that a patient receiving a therapeutic dose of ibogaine or a pharmaceutically acceptable salt thereof is monitored in a clinical setting (Col. 39, lines 38-41). Friedhoff teaches that prescreening comprises determining the patient’s pre-treatment QT interval (e.g., baseline QT interval prior to administering ibogaine) (Col. 40, lines 26-28).
Caron teaches the prophylactic administration of intravenous magnesium sulfate prevents increases in the QT and QTc interval 30 minutes after the last infusion of ibutilide (Abstract). Caron teaches that increase in QT interval duration with class III agents enhance the risk of torsades de pointes (Page 296, Col. 2, 1st full paragraph). Caron teaches intravenous infusion of magnesium sulfate 2g (e.g., 2000 mg) or placebo is administered to patients immediately (e.g., provide a concentration of magnesium in the blood for a period of time) before starting ibutilide therapy (e.g., drug causing QT administered at a period of time that the magnesium is provided at a concentration in the blood) (Page 297, Col. 2, 1st ¶). Caron teaches an additional 2 g intravenous magnesium sulfate administered after the first dose of ibutilide (Page 297, Col. 2, 1st ¶). Caron teaches that QT interval increased 29% from baseline at 30 minutes after the last dose of ibutilide in placebo group, but no significant change from baseline occurred in the magnesium sulfate group at the same time point (Page 298, ¶ bridging Col. 1 and Col. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of treating a neuropsychiatric disorder of the brain, including reducing excitotoxic brain damage due to trauma or other forms of neuronal injury or degeneration by administering ibogaine as a safe NMDA antagonist, as taught by Olney, in view of the clinical monitoring of patients undergoing pain treatment by the administration of ibogaine to ensure that QT interval is not prolonged beyond a certain value, as taught by Friedhoff, and the administration of magnesium sulfate to prevent increases in the QT interval after administration of ibutilide therapy, which is a drug that causes an increase in QT interval, as taught by Caron, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do this in order to prevent prolongation of QT interval caused by ibogaine, which is taught by Friedhoff (Abstract, Col. 2, lines 17-19, Col. 39, lines 24-30 and 38-41), by administering magnesium sulfate to prevent increases in the QT interval after administration of a drug that causes an increase in QT interval, as taught by Caron (Abstract, Page 297, Col. 2, 1st ¶ and Page 298, ¶ bridging Col. 1 and Col. 2). One of ordinary skill in the art would have reasonably expected success because Olney discloses ibogaine used at relatively high dosages to reduce or prevent excitotoxic brain damage due to including trauma (e.g., mechanical injury/traumatic brain injury (TBI)) (Col. 7, lines 31-35; Col. 11, lines 26-30).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claim 19, the limitation of treating a neuropsychiatric disorder of the brain would have been obvious over the treatment of excitotoxic brain damage due to stroke, cardiac arrest, trauma or other forms of neuronal injury or degeneration (Abstract, Col. 11, lines 26-38), as taught by Olney.
Regarding instant claim 19, the limitation of administering to a subject with a neuropsychiatric disorder of the brain a cardioprotective agent in an amount effective to achieve a physiologic effect to reduce risk associated with drug-induced prolonged QT interval, wherein the cardioprotective agent is a salt of magnesium would have been obvious over the administration of magnesium sulfate in patients to prevent increases in the QT interval after administration of a drug that causes an increase in QT interval, as taught by Caron (Abstract, Page 297, Col. 2, 1st ¶ and Page 298, ¶ bridging Col. 1 and Col. 2).
Regarding instant claim 19, the limitation of administering ibogaine or a salt thereof would have been obvious over the administration of ibogaine as a safe NMDA antagonist to reduce or prevent excitotoxic brain damage due to stroke, cardiac arrest, trauma or other forms of neuronal injury or degeneration, without causing the neurotoxic side effects caused by other NMDA antagonist drugs (Abstract), as taught by Olney.
Regarding instant claim 20, the limitation of treating a symptom of a neuropsychiatric disorder of the brain in a subject would have been obvious over the method to reduce or prevent excitotoxic brain damage due to stroke, cardiac arrest, trauma or other forms of neuronal injury or degeneration, without causing the neurotoxic side effects caused by other NMDA antagonist drugs (Abstract), as taught by Olney.
Regarding instant claims 20 and 31, the limitations of instructing the subject to self-administer one or more doses of a cardioprotective agent, wherein the cardioprotective agent is a salt of magnesium would have been obvious over the administration of magnesium sulfate to prevent increases in the QT interval after administration of a drug that causes an increase in QT interval, as taught by Caron (Abstract, Page 297, Col. 2, 1st ¶ and Page 298, ¶ bridging Col. 1 and Col. 2). One of ordinary skill in the art would have found it obvious to provide appropriate instructions to the patient based on the severity of the symptoms and the optimal therapeutic outcome.
Regarding instant claim 20, the limitation of administering a unit dose of ibogaine or salt thereof would have been obvious over the administration of ibogaine as a safe NMDA antagonist to reduce or prevent excitotoxic brain damage due to stroke, cardiac arrest, trauma or other forms of neuronal injury or degeneration, without causing the neurotoxic side effects caused by other NMDA antagonist drugs (Abstract), as taught by Olney.
Regarding instant claim 20, the limitation of monitoring the subject while under clinical or medical supervision after administering the unit dose of ibogaine to determine if a further dose of the cardioprotective agent is needed would have been obvious over the patient receiving a therapeutic dose of ibogaine or a pharmaceutically acceptable salt thereof who is monitored in a clinical setting (Col. 39, lines 38-41), as taught by Friedhoff.
Regarding instant claims 21 and 34, the limitations of magnesium sulfate would have been obvious over the administration of magnesium sulfate (Abstract, Page 297, Col. 2, 1st ¶ and Page 298, ¶ bridging Col. 1 and Col. 2), as taught by Caron.
Regarding instant claim 22, the limitation of the amount of magnesium sulfate which is an amount to provide a concentration of magnesium in the blood for a period of time would have been obvious over the administration of magnesium sulfate by intravenous infusion in a concentration of 2 g in 50 mL of 0.9% sodium chloride over 10 minutes before starting ibutilide therapy (Abstract, Page 297, Col. 2, 1st ¶ and Page 298, ¶ bridging Col. 1 and Col. 2), as taught by Caron. Once the magnesium sulfate is administered the magnesium will naturally be released in the blood of the patient and will provide a concentration of magnesium in the blood.
Regarding instant claim 22, the limitation of said administering ibogaine or salt thereof comprising administering during the period of time would have been obvious over the administration of ibogaine as a safe NMDA antagonist to reduce or prevent excitotoxic brain damage due to stroke, cardiac arrest, trauma or other forms of neuronal injury or degeneration, without causing the neurotoxic side effects caused by other NMDA antagonist drugs (Abstract), as taught by Olney.
Regarding instant claim 23, the limitation of said administering ibogaine or salt thereof comprising orally administering would have been obvious over the oral administration (Col. 14, lines 51-57), as taught by Olney.
Regarding instant claims 24 and 35, the limitations of ibogaine hydrochloride would have been obvious over the non-toxic and pharmacologically acceptable salts of ibogaine (Col. 14, lines 10-16), including pharmaceutically acceptable acid addition salts such as hydrochloric acid (Col. 14, lines 20-32), as taught by Olney.
Regarding instant claim 25, the limitation of the amount of ibogaine or salt thereof that induces long QT syndrome would have been obvious over the use of ibogaine which imparts a dose dependent prolongation of the treated patient’s QT interval (Col. 2, lines 17-19), as taught by Friedhoff.
Regarding instant claim 26, the limitation of the amount of ibogaine or salt thereof of between about 200-2500 mg would have been obvious over the preferred dosage of ibogaine within the range of from about 5 to about 100 mg/kg per day if taken orally (¶ bridging Col. 15 and Col. 16), as taught by Olney, which is calculated to be an overlapping range of about 350 mg to about 7000 mg for a 70 kg person. According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Regarding instant claim 27, the limitation of assessing a baseline QT interval would have been obvious over the pre-screening of patients before treatment with ibogaine or a pharmaceutically acceptable salt thereof and monitoring of patients (e.g., under clinical or medical supervision) during ibogaine or a pharmaceutically acceptable salt thereof during treatment to ensure that QT interval is not prolonged beyond a certain value (Col. 39, lines 24-30), as taught by Friedhoff. Furthermore, Friedhoff also teaches that a patient receiving a therapeutic dose of ibogaine or a pharmaceutically acceptable salt thereof is monitored in a clinical setting (Col. 39, lines 38-41), and that prescreening comprises determining the patient’s pre-treatment QT interval (e.g., baseline QT interval prior to administering ibogaine) (Col. 40, lines 26-28).
Regarding instant claims 29 and 33, the limitations of traumatic brain injury would have been obvious over the trauma or mechanical injury to the brain where many trauma victims suffer from a dangerous and potentially lethal increase in intracranial pressure, which involves water flowing into neurons in an effort to sustain osmotic balance as charged ions flow into the neurons during neuronal excitation (Col. 11, lines 26-38), as taught by Olney.
Claims 28, 30, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Olney (US 5,629,327) in view of Friedhoff (US 9,561,233), Caron et al. (Pharmacotherapy, 23(3), pp. 296-300, 2003 – “Caron”), and Bahado-Singh (US 2020/0165680 A1).
Instant claim 28 is drawn to the method of claim 19, wherein the subject is experiencing a symptom associated with the neuropsychiatric disorder of the brain, wherein the symptom is selected from depression, anxiety and suicidal ideation.
The teachings of Olney, Friedhoff, and Caron are discussed above.
Olney, Friedhoff, and Caron do not expressly teach a symptom selected from depression, anxiety and suicidal ideation.
Bahado-Singh teaches detection of traumatic brain injury (Abstract). Bahado-Singh teaches that traumatic brain injury severity can be mild, moderate and severe depending on the extent of damage to the brain, patients level of consciousness and reactions to stimuli ([0040]). Bahado-Singh teaches that drugs used for treating traumatic brain injuries include NMDA antagonists ([00124]). Bahado-Singh teaches that during early post traumatic periods symptoms including depression can develop and can persist for many months ([0016]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of treating a neuropsychiatric disorder of the brain, including reducing excitotoxic brain damage due to trauma or other forms of neuronal injury or degeneration by administering ibogaine as a safe NMDA antagonist, as taught by Olney, in view of the clinical monitoring of patients undergoing pain treatment by the administration of ibogaine to ensure that QT interval is not prolonged beyond a certain value, as taught by Friedhoff, the administration of magnesium sulfate to prevent increases in the QT interval after administration of ibutilide therapy, which is a drug that causes an increase in QT interval, as taught by Caron, and the symptoms during early post traumatic periods which include depression that is persistent for many months, as taught by Bahado-Singh, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to combine the teachings of the cited prior art references because Olney and Bahado-Singh teach the treatment of traumatic brain injury with an NMDA antagonist. It is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A). One of ordinary skill in the art would have had a reasonable expectation of success in treating traumatic brain injury with an NMDA antagonist such as an ibogaine or salt thereof, and successfully treat the symptoms associated with the traumatic brain injury, such as depression, as taught by Bahado-Singh.
Regarding instant claims 28 and 32, the limitations of depression would have been obvious over the symptoms of depression that can develop during early post traumatic periods and can persist for many months ([0016]), as taught by Bahado-Singh.
Regarding instant claim 30, the limitation of traumatic brain injury comorbid with post-traumatic stress disorder would have been obvious over the traumatic brain injury (Abstract, [0040]) and the post traumatic period symptoms such as decline of cognition (difficulty concentrating, distractedness, forgetfulness), headaches, dizziness, fatigue, depression, and post traumatic sleep disorder ([0016]), as taught by Bahado-Singh.
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 19-35 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-14 of copending Application No. 18/818,513 (the ‘513 Application).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method for treating a neuropsychiatric disorder of the brain, comprising: administering to a subject with a neuropsychiatric disorder of the brain a cardioprotective agent in an amount effective to achieve a physiologic effect to reduce risk associated with drug-induced prolonged QT interval, wherein the cardioprotective agent is a salt of magnesium; and administering ibogaine or a salt thereof, and therefore, encompass overlapping or coextensive subject matter.
One difference is that claims of the ‘513 Application recite treating chronic traumatic brain injury whereas instant claims 29, 30, and 33 recite only traumatic brain injury. However, there is patient overlap between the patient populations having traumatic brain injury and chronic traumatic brain injury, thereby rendering this limitation obvious.
Another difference is that claim 1 of the ‘513 Application recites administering a first amount of a magnesium salt whereas instant claims don’t recite a first amount of a magnesium salt. However, since instant claims recite the transitional phrase “comprising,” this is considered open language, and allows administration of additional amounts, including a first, second, or third amount of a magnesium salt.
Therefore, instant claims are obvious over claims of the ‘513 Application, and they are not patentably distinct over each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 19-35 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 11 and 21-29 of copending Application No. 18/467,343 (the ‘343 Application).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method for treating a neuropsychiatric disorder of the brain, comprising: administering to a subject with a neuropsychiatric disorder of the brain a cardioprotective agent in an amount effective to achieve a physiologic effect to reduce risk associated with drug-induced prolonged QT interval, wherein the cardioprotective agent is a salt of magnesium; and administering ibogaine or a salt thereof, and therefore, encompass overlapping or coextensive subject matter.
One difference is that claims of the ‘343 Application recite obtaining image data from an image of a subject’s brain and analyzing the image data, whereas instant claims don’t recite this limitation.
However, instant claims recite the transitional phrase “comprising” which is considered open language and allows the inclusion of additional components and steps. One of ordinary skill in the art would have found it obvious to obtain an image of the patient’s brain prior to initiating treatment to have a baseline and to compare future images with the baseline to monitor improvement, and in order to efficaciously treat the patient and ensure that the brain imaging supports the treatment, dosage, and regimen.
Therefore, instant claims are obvious over claims of the ‘343 Application, and they are not patentably distinct over each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 19-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 11-13 of U.S. Patent No. 12,396,997 B2 (the ‘997 Patent).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method for treating a neuropsychiatric disorder of the brain, comprising: administering to a subject with a neuropsychiatric disorder of the brain a cardioprotective agent in an amount effective to achieve a physiologic effect to reduce risk associated with drug-induced prolonged QT interval, wherein the cardioprotective agent is a salt of magnesium; and administering ibogaine or a salt thereof, and therefore, encompass overlapping or coextensive subject matter.
The difference is that claim 1 of the ‘997 Patent recites a patient population having a neuropsychiatric condition selected from traumatic brain injury and post-traumatic stress disorder, whereas instant claim 19 just recites a patient population having a neuropsychiatric disorder.
However, instant claims 29 and 33 recite that the neuropsychiatric disorder of the brain is traumatic brain injury or post-traumatic stress disorder; and instant claim 30 recites that the neuropsychiatric disorder of the brain is traumatic brain injury comorbid with post-traumatic stress disorder, thereby rendering these limitations obvious.
Another difference is that claim 1 of the ‘997 Patent recites monitoring the subject by analyzing image data from a brain image to determine a predicted brain age.
However, instant claims recite the transitional phrase “comprising” which is considered open language and allows the inclusion of additional components and steps. One of ordinary skill in the art would have found it obvious to monitor the subject undergoing treatment for traumatic brain injury and post-traumatic stress disorder, which is recited in both sets of claims, in order to efficaciously treat the patient and ensure the brain imaging supports the treatment, dosage, and regimen.
Therefore, instant claims are obvious over claims of the ‘997 Patent and they are not patentably distinct over each other.
Conclusion
No claims are allowed.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615