DETAILED ACTION
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 . 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.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 11-29, in the reply filed on 12/02/2025, is acknowledged. Applicant’s election without traverse of MRI (species of imaging technique); magnesium sulfate (species of electrolyte salt); the electrolyte salt of magnesium sulfate (species of cardioprotective agent), in the reply filed on 12/02/2025, is acknowledged.
Claim Rejections - 35 USC § 103 - Obviousness
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.
Claim(s) 11-21 and 23-29 are rejected under 35 U.S.C. 103 as being unpatentable over Weis et al (WO 2017/184531A1), in view of Tzivoni et al (Circulation, 77(2), 392-397, 1988) and further in view of Sieminow et al (US 2020/0357119A1).
Weis taught a method for treating a neurodegenerative disease (e.g., traumatic brain injury, [0009]) and/or symptoms thereof in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of an iboga alkaloid or pharmaceutically acceptable salt or solvate thereof [claim 1]. The treatment provided preventing symptoms and/or progression thereof, by administering a therapeutic amount (or prophylactic amount), of ibogaine, to result in a QT interval prolongation of less than 60 ms, preferably less than 50 ms, more preferably less than 30 ms, even more preferably less than 20 ms [0006-007,claim 34].
Weiss did not teach administering magnesium sulfate, as instantly elected; obtaining and analyzing brain image data, as recited in claim 11.
Tzivoni taught that magnesium sulfate, MgSO4, reduces the QT interval in patients with marked QT prolongation. MgSO4 is a very safe and effective treatment, and is recommended as a therapy in patients with QT prolongation [abstract].
Since Weiss generally taught treating the progression of the QT interval, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Weiss, magnesium sulfate, as taught by Tzivoni. The ordinarily skilled artisan would have been so motivated, because MgSO4, reduces the QT interval in patients with marked QT prolongation. As per Tzivoni, MgSO4 is a very safe and effective treatment, and is recommended as a therapy in patients with QT prolongation [abstract].
The combined teachings of Weiss and Tzivoni did not teach obtaining and analyzing brain image data.
Sieminow taught a method for determining a brain age, the method comprising the following:
(a) providing a brain age determining convolutional neural network (CNN);
(b) training the CNN to determine the brain age, based on a plurality of sets of input data comprising magnetic resonance imaging (MRI) scans of a brain; and
(c) performing an inference process using the trained CNN to determine the brain age (e.g., reads on analyzing image data) [claim 1], where neuroimaging-derived age predictions are explored in order to understand brain aging, and to identify biomarkers of the process, as vital for improving the detection of neurodegeneration and to predict cognitive decline [0002].
As per Siemionow, the human brain changes across the adult lifespan. This process of brain aging occurs in parallel to a general decline in cognitive performance, known as cognitive aging. Although the changes associated with brain aging are not explicitly pathological, with increasing age comes increased risk of neurodegenerative disease. However, brain disease can start at any age, therefore the effects of aging on the brain vary greatly between individuals. Thus, advancing the understanding of brain aging and identifying biomarkers (e.g., brain age or age-based algorithms, [0006, 0040, 0055]) of the process is vital for improving the detection of early-stage neurodegeneration [0002].
By training models (e.g., training models are repeated continuously [0052, 0055, 0076]) on individuals, brain-based predictions of age are made. If ‘brain-predicted age’ is greater than an individual's chronological age, this may reflect some aberrant accumulation of brain injury. The degree of this ‘added’ brain aging can be quantified by subtracting chronological age from brain-predicted age [0003].
Since Weis generally taught a method for treating neurodegenerative disease, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Weiss, obtaining and analyzing brain image data, as taught by Siemionow. The ordinarily skilled artisan would have been so motivated, because neuroimaging-derived age predictions help to understand brain aging, as vital for improving the detection of neurodegeneration, and to predict cognitive decline, as taught by Sieminow at claim 1 and at ¶s [0002-0003].
Weis, in view of Tzivoni and Sieminow, reads on claims 11-15, 20-21, 23 and 26-28.
Claims 16-19 are rendered prima facie obvious because Weis taught administering once, twice, three times, four times or five times daily. In some embodiments, the administration was once daily, or once every second day, once every third day, three times a week, twice a week, or once a week (e.g., reads on repeating). The dosage and frequency of the administration may depend on the route of administration [0187]. Weiss taught oral, sublingual, buccal, intrapulmonary, or intranasal delivery [0189]. Tzivoni taught continuous infusion [abstract].
Claims 24-25 and 28-29 are rendered prima facie obvious because Weis taught doses of iboga alkaloid or pharmaceutically acceptable salt or solvate thereof, at about 50 mg to about 200 mg [0196]. The hydrochloride salt of ibogaine was taught [0130]. Magnesium salts were taught at [0132].
The instant claim 24 recites an amount between 250-2500 mg.
The instant claim 29 recites magnesium salt at 50-8000 mg.
Weis taught doses of about 50 mg to about 200 mg. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. MPEP 2144.05 A.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Weis et al (WO 2017/184531A1), in view of Tzivoni et al (Circulation, 77(2), 392-397, 1988), further in view of Sieminow et al (US 2020/0357119A1) and further in view of Maillet et al (US 2016/0074414A1).
The 35 U.S.C. 103 rejection over Weis, in view of Tzivoni and Sieminow, was previously discussed.
Although Weis generally taught administering ibogaine, as previously discussed, Weis did not teach post-traumatic stress disorder, as recited in claim 22.
Maillet taught administering to a patient in need thereof, a therapeutically effective amount of ibogaine, for treating anxiety-related disorders [abstract], including post-traumatic stress disorder [0118], where the dose range of ibogaine provided both therapeutic results, and an acceptable QT interval prolongation of less than about 50 milliseconds, or less than about 20 milliseconds [0013-0014, 0020, 0022, 0161].
Since Weis taught administering ibogaine, where the administration did not result in a QT interval prolongation of less than 50 ms, more preferably less than 30 ms, even more preferably less than 20 ms, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Weis, post-traumatic stress disorder, as taught by Maillet. The ordinarily skilled artisan would have been so motivated, because ibogaine is known to treat post-traumatic stress disorder, as taught by Maillet [0118].
Nonstatutory Double Patenting
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 11-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-35 of copending Application No. 18/437,324, in view of Sieminow et al (US 2020/0357119A1). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 11-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of copending Application No. 18/818,513, in view of Sieminow et al (US 2020/0357119A1). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 11-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,396,997, in view of Sieminow et al (US 2020/0357119A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims require obtaining and analyzing image data, further limited to MRI, which is not required of the copending and issued claims.
Sieminow taught a method for determining a brain age, the method comprising the following:
(a) providing a brain age determining convolutional neural network (CNN);
(b) training the CNN to determine the brain age based on a plurality of sets of input data comprising magnetic resonance imaging (MRI) scans of a brain; and
(c) performing an inference process using the trained CNN to determine the brain age (e.g., reads on analyzing image data) [claim 1], where neuroimaging-derived age predictions are explored in order to understand brain aging, and to identify biomarkers of the process, as vital for improving the detection of neurodegeneration and to predict cognitive decline [0002].
As per Siemionow, the human brain changes across the adult lifespan. This process of brain aging occurs in parallel to a general decline in cognitive performance, known as cognitive aging. Although the changes associated with brain aging are not explicitly pathological, with increasing age comes increased risk of neurodegenerative disease. However, brain disease can start at any age therefore the effects of aging on the brain vary greatly between individuals. Thus, advancing our understanding of brain aging and identifying biomarkers (e.g., brain age or age-based algorithms, [0006, 0040, 0055]) of the process is vital for improving the detection of early-stage neurodegeneration [0002].
By training models (e.g., training models are repeated continuously [0052, 0055, 0076]) on individuals, brain-based predictions of age are made. If ‘brain-predicted age’ is greater than an individual's chronological age, this may reflect some aberrant accumulation of brain injury. The degree of this ‘added’ brain aging can be quantified by subtracting chronological age from brain-predicted age [0003].
It would have been prima facie obvious to one of ordinary skill in the art to include, within the copending and issued claims, obtaining and analyzing brain image data, as taught by Siemionow. The ordinarily skilled artisan would have been so motivated, because neuroimaging-derived age predictions help to understand brain aging, as vital for improving the detection of neurodegeneration and to predict cognitive decline, as taught by Sieminow.
Claims 11-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/901,503.
Although the claims at issue are not identical, they are not patentably distinct from each other because the species (systems and methods for confirming iboga alkaloid treatment) recited in the copending claims falls within the genus (methods of treatment with an iboga alkaloid) recited in the claims of the instant application, and thus read on the instant claims.
Conclusion
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612
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