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 .
Status of the Claims
Claims 1-18 are pending and examined.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 6-8 and 10-18 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Ivaturi et al., (US2019/0307343) (cited in IDS).
Ivaturi teaches administering sotalol hydrochloride (par. 77) wherein an IV dose can be 40-80 mg infused over 1-2 hours followed by an oral maintenance dose of 80-160 mg BID. See Figure 6, e.g. The cardiovascular condition to be treated includes atrial fibrillation or flutter, among others. See par. 23. The subject can be naïve to sotalol. See Figure 8. The treatment can occur at a hospital, which is defined as a facility with the claimed capabilities. See Specification @ par.’s 3, 28, 33, and 35. The methods appear to contemplate oral administration immediately after infusion. This would be in a hospital as immediate would mean prior to leaving as an infusion would be in a hospital. Further, methods contemplate an oral dose 2 hours from the start of an infusion that lasts 1 hour. This could be in or out of a hospital. It does not appear that this aspect is critical and a POSA would immediately envisage both scenarios in view of the teachings of the cited prior art. Certainly, a maintenance dose administered at 12 hours or 24 hours after start of infusion would be after release from a hospital. See prior art claims 19-22, Figure 8. A subject that needs to be re-initiated after a surgical procedure is not being put on sotalol necessarily based on a present abnormal sinus rhythm, but rather a historical need for the drug. This would not be dependent upon the patient’s sinus rhythm at that particular time and the examiner interprets this to include those that have normal and abnormal sinus rhythm. Sotalol is known for use in treating ventricular arrythmias. See par.’s 2 and 3. Ivaturi teaches obtaining a baseline QTc prior to treatment and then monitoring the same after each dose to determine if a second and potentially third IV dose can be administered prior to a switch to oral administration. See par. 29. The examples provided in an oral dose that is increased relative the IV loading dose. See Figures 4 and 6, among others.
As such, claims 1, 6-8 and 10-18 are anticipated by the prior art.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ivaturi et al., (US2019/0307343) (cited in IDS).
Ivaturi teaches sotalol is used to treat ventricular arrhythmia and atrial fibrillation (AF) or flutter. See par. 3. It can be used for maintenance of normal sinus rhythm as well as acute management of ventricular arrhythmias. Ivaturi teaches administering sotalol in a manner that allows for intravenous sotalol administered and a patient can be converted to oral sotalol to increase hospital flexibility, convenience, and to save money, regardless of whether they have normal or abnormal renal function. See par. 27 and par. 33. Treatment is for atrial fibrillation or flutter, e.g. See par. 3. Typically a subject is required to stay at a hospital for three days prior to discharge. See par. 35. Ivaturi teaches monitoring maximum QTc prolongation and changes in prolongation relative to a baseline measurement. The provisional application also teaches that the relationship between sotalol concentration and QTc is linear and enables a reliable prediction of QTc prolongation using baseline QTc. In view of the teachings as a whole in the provisional application, whether a threshold of 20% or another threshold is used, when QTc changes too much, infusions can cease any point. See p7. Further, a specific risk is taught to be calculated based on a calculated relationship relative to a subject’s baseline. The claims merely require ceasing infusions if QTc differs by more than 20%. This includes the most obvious and drastic of scenarios. For example, if QTc changes 80%, infusions would cease. Alternatively, if there is no change (i.e., 0% from baseline), a POSA would understand that this indicates the subject is tolerating sotalol well.
Further, a patient can be treated whether they have normal or abnormal renal function. See par. 31. A subject will be administered a lower dosage or a less frequent dosage if they are known to have renal impairment, such as every 24 hours with impairment rather than every 12 hours, e.g. The methods described allow for a reduction of a hospital stay to 24 hours by accelerating parameters, such as Cmax. See par. 44. Further, after surgery re-initiation of sotalol can re-stabilize Cmax. See par. 47. QTc interval is able to be kept below 500 msec throughout this process. See par. 49. In an example, oral sotalol was administered at a dosage of 80, 120, and 160 mg twice daily. See par. 5 and Figure 2. Further, embodiments include administering an intravenous dosage initially over a period of 30 minutes to 2 hours. See par. 7. Sotalol hydrochloride is a form prescribed for injection. See par. 5. Further, IV loading doses are shown in Figure 4 to be 1-3 hours and include a dose of up to 80 mg in a subject that was on a prior stable dose of 80 mg. Figure 8 provides additional examples in which a target oral maintenance dose can range from 80 mg to 160 mg. Further, dose titration includes administering an IV dose of about 80 mg over 2 hour prior to a 160 mg oral dose; 60 mg infusion over 1.5 hours prior to a 120 mg oral dose; or a 40 mg infusion over 1 hour prior to a 80 mg oral dose. See Figure 8.
Ivaturi teaches a mixed dose method wherein a single IV dose is immediately followed by an oral administration. It is abundantly clear that dose titration is taught and conveys to a POSA that is should be done and appears to be required to be guided through clinical response. As such, if a subjects requires an increase in dosage, they could be administered IV sotalol under QTc monitoring and have their Cmax, ss achieved rapidly to ensure the dose is safe. At that time, they could be transitioned to oral maintenance dosing as taught by Ivaturi. This would impart the benefits taught by Ivaturi to include a shorter hospital stay and a cost savings, among others.
This is particularly the case given the predictability of pharmacokinetic parameters, including Cmax, ss, and Tmax, the known bioavailability of oral compared to IV sotalol, and the known QTc-concentration relationship, among others.
With regard to claim 8, Ivaturi teaches treating sotalol naïve patients. See Fig. 8 and par. 48. Figure 8 shows target oral maintenance doses to include 80, 120, 160 mg BID, and starts with a IV dose of 40-80 mg over 2 hours, e.g.
Ivaturi explains that the rapid infusion of sotalol is known to be safe. Ivaturi explains that IV infusions as rapid as 5 minutes have been without incident. In examples, Ivaturi teaches administration of an IV infusion of 40 mg, followed by an IV infusion of 20 mg, and followed by an IV infusion of 20 mg. This is an 80 mg infusion, e.g., over a period of 2 hours. Ivaturi explains a goal to accelerate dosing of Cmax, ss to as early as 1 day. In some embodiment, Cmax, ss is achieved within 4 hours of initiation of treatment (i.e., 2 hours after completion of a 2 hour IV regimen) in a method wherein one IV infusion or more are followed by oral administration. See par. 61. In some cases, an oral dose can immediately follow IV administration (i.e., a mixed dosing regimen is also contemplated). In other embodiments, at the end of a 2-hour infusion, an 80 mg dose can be administered followed by another 80 mg dose 12 hours after the initiation of infusion. Similar achievement for 120 mg and 160 mg oral doses can also be achieved through such regimen. Thus, regardless of the ultimate maintenance dosage desired, the ability administer rapid IV sotalol followed by oral sotalol is predictable. Cmax is known to be a function of length of infusion and dose-proportionate linear pharmacokinetics for sotalol. Treatment of naïve patients is also contemplated. See par.’s 44, 47, 49, and others.
Ivaturi also teaches a first infusion of 10 mg to 60 mg over 0.5 hours. See prior art claim 4. Then, a second infusion can be over 0.5 hours after the start of the first infusion. This second infusion is 10 to 40 mg. This equates to 100 mg over 1 hour and falls within the scope of the instant claims. Further, a third infusion of 10 mg to 30 mg starting 0.5 hours after the start of the second infusion is claimed. See prior art claims 12 and 13, e.g. Thus, Ivaturi claims administering 100 mg over 1 hour and 130 mg over 1.5 hours. While these administration may not be in a “single” IV dosage, the dosing regimen overlaps.
With regard to claim 9, Ivaturi teaches in the background section that standard prescribing information for sotalol injection includes a 5 hours infusion to mimic the PK of oral therapy. As such, administration over 5 hours could be a starting point for treatment. Further, a previous standard for AF included titration of 80 mg BID to a titration of up to 360 mg/day. The bioavailability is similar to oral and IV sotalol. See par. 5.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’" In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Optimizing a dosage of a known-result effective variable with predictable trends in pharmacokinetic parameters would require nothing more than routine experimentation, including in those subjects with varying degrees of renal function, as explicitly taught by Ivaturi.
With regard to claims 10, 11, 13, and the limitation “admitted to a facility capable of providing cardiac resuscitation and continuous electrographic monitoring” the examiner notes that this is interpreted to include a hospital, as described in paragraph 90 of the instant Specification. Ivaturi teaches treating a subject in a hospital. See par. 5. While it can include other facilities, the prior art teaches this. Standard treatment is recommended to be at a hospital and monitoring is recommended until steady state is achieved. See par. 5.
It would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the instant application to arrive at the claimed invention in view of Ivaturi. One would be motivated to do so because Ivaturi teaches advantages of converting a subject from IV sotalol to oral sotalol in a manner that reduces hospital stay, increases convenience and reduces cost. This is done safely and effectively by allow a patient to be monitored for QTc prolongation three times within a short period of time so that conversion can be rapid. This is taught to be possible regardless of renal abnormality. Further, Ivaturi explains that as renal function decreases, the dose of sotalol and/or the frequency of administration of sotalol must be decreased. Ivaturi teaches the safety of broad dosage ranges and the ability to provide infusions over longer periods of time or rapidly. Administration prior to the Ivaturi is prescribed as a 5 hours infusion. Ivaturi teaches rapid infusion over 1-3 hours, although rapid infusion over 5 minutes has been shown to be safe. There is no reason that longer infusion would not be considered as this is the standard practice. However, a shorter infusion can allow for faster stabilization for patient release. Typically, the dosages taught by Ivaturi include a 40, 60 or 80 mg infusion followed by oral dosages of 80, 120, or 160 mg up to twice daily. These are the standard doses known to be used. The pharmacokinetics of sotalol are shown by Ivaturi at different dosages and there is a predictability shown for the same. Using higher or lower loading doses and/or maintenance doses would appear to include optimizable doses based on patient tolerability, weight, agent, renal function, and other parameters. While many dosage regimens are safe with predictable PK, Ivaturi provides an example in which an IV dose is approximately 50% lower than the oral dose to be titrated to. Ivaturi teaches broad ranges for IV dosage administration over the first couple of hours to be later converted to an oral dose that can be administered periodically and also outside of a hospital facility. As such, there is a reasonable and predictable expectation of success in arriving at the claimed methods in view of Ivaturi.
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Batul et al., “Intravenous Sotalol- Reintroducing a Forgotten Agent to the Electrophysiology Therapeutic Arsenal,” Journal of Atrial Fibrillation, Feb-Mar 2017, Vol 9, Issue 5 (cited in IDS), in view of Li et al., “Efficacy of Intravenous Sotalol for Treatment of Incessant Tacharrhythmias in Children,” Am J Cardiol 2017; 119:1366-1370 (cited in IDS), in view of Somberg et al., “Developing a safe intravenous sotalol dosing regimen,” Am J Ther, 2010 Jul-Aug; 17(4): 365-72 (cited in IDS), in view of Saul et al., “Pharmacokinetics and pharmacodynamics of sotalol in a pediatric population with superventricular and ventricular tacharrhythmia,” Clinical Pharmacology and Therapeutics, March 2001 (cited in IDS), and in view of Ivaturi et al., (US2019/0307343) (cited in IDS).
Batul teaches sotalol for treatment of atrial fibrillation (AF) and atrial flutter (AFL). Batul explains that the safety principles applicable to oral sotalol are valid for intravenous sotalol as well. The bioavailability of oral sotalol is 93% with peak plasma concentrations in 2.5 to 4 hrs. Batul indicates that IV sotalol dosage includes administering 1-1.5 mg/kg over 5-30 minutes. In a 30 kg pediatric subject, this would include 30-45 mg over 5-30 minutes, and in a 70 kg human, this would include 70-105 mg over 5-30 minutes. This rate of infusion is substantially more rapid than claimed and well under a 1 hour infusion time. Batul explains that risk increases when QTc is above 500 msec and shows a linear correlation to sotalol blood levels. See p2, 5th full par. High dose rapid therapy was shown to be safe and efficacious in suppressing SVT in 90% of patients aged 7 to 728 days, with no proarrhythmic effect or QTc prolongation observed. See p4. Further, it has an elimination half-life of 12-16 hours. See p3, 3rd full par. Further, Table 1 below explains the dose conversion for oral and intravenous forms.
PNG
media_image1.png
215
822
media_image1.png
Greyscale
Batul explains IV sotalol can be a substitute for oral medication, such as for post-operative and critically ill subjects, especially when they have reduced GI permeability and absorption for oral administrations to reach effective serum concentrations. See p3, 1st full par. In other instances, IV forms provide advantages as compared to oral forms because it reaches therapeutic levels quicker and could be used in hospitals to facilitate a transition to oral forms.
Li teaches treating patients with IV sotalol and those subjects that maintained sinus rhythm were transitioned to oral therapy. See p1367, par. 7. Subjects that were treated have AVRT, AT, Aflutter, AF, and VT. See Table 1. Any patient with a QTc above 480 was converted to oral sotalol therapy. See p1367, par. 4. Li used a loading dose of 1 mg/kg over 10 minutes and then 4.5 mg/kg/day. See p1369, last full par. Thus, Li shows a reasons that subjects taking IV will be transitioned to oral sotalol.
Li explains that for patients with atrioventricular reentrant tachycardia who converted to sinus rhythm on sotalol within 2 hours, IV sotalol was continued for another 1 to 24 hours and then transitioned to oral therapy. See p1367, 1st par. In other words, patients were converted to oral therapy in as few as 3 hours after starting the IV dose.
Further, Somberg teaches Cmax is known to be a function of length of infusion, wherein increasing duration of infusion decreases Cmax.
Saul teaches, “An examination of the individual data of the smallest patients did not indicate any deviation from dose-proportionate linear pharmacokinetics for sotalol.” P150, 1st full par. These data are shown below in Table III. QTc interval was dose dependent. The steady state pharmacokinetics of sotalol was dose proportionate. See Abstract. A dose of 30 mg/m2 yielded a SS Cmax of 851 +/- 185.
PNG
media_image2.png
568
1546
media_image2.png
Greyscale
The pediatric patients receiving multiple doses of sotalol achieved ideally small fluctuation factor values between peak and steady state and experienced a dose-proportionate response. Further, there were linear correlations between drug concentration and pharmacological activity on the QTcB interval. See p155, last par.
Ivaturi teaches administering sotalol in a manner that allows for intravenous sotalol administered and a patient can be converted to oral sotalol to increase hospital flexibility, convenience, and to save money, regardless of whether they have normal or abnormal renal function. See par. 27 and par. 33. Typically a subject is required to stay at a hospital for three days prior to discharge. See par. 35. Ivaturi teaches monitoring maximum QTc prolongation and changes in prolongation relative to a baseline measurement. The provisional application also teaches that the relationship between sotalol concentration and QTc is linear and enables a reliable prediction of QTc prolongation using baseline QTc. In view of the teachings as a whole in the provisional application, whether a threshold of 20% or another threshold is used, when QTc changes too much, infusions can cease any point. See p7.
Further, a specific risk is taught to be calculated based on a calculated relationship relative to a subject’s baseline. The claims merely require ceasing infusions if QTc differs by more than 20%. This includes the most obvious and drastic of scenarios. For example, if QTc changes 80%, infusions would cease. Alternatively, if there is no change (i.e., 0% from baseline), a POSA would understand that this indicates the subject is tolerating sotalol well.
Further, a patient can be treated whether they have normal or abnormal renal function. See par. 31. More specifically, a subject will be administered a lower dosage or a less frequent dosage if they are known to have renal impairment, such as every 24 hours with impairment rather than every 12 hours, e.g. In other words, a subject with impaired renal function will receive a lower dose or receive administration less frequently. The methods described allow for a reduction of a hospital stay to 24 hours by accelerating parameters, such as Cmax. See par. 44. Further, after surgery re-initiation of sotalol can re-stabilize Cmax. See par. 47. QTc interval is able to be kept below 500 msec throughout this process. See par. 49. In an example, oral sotalol was administered at a dosage of 80, 120, and 160 mg twice daily. See par. 5 and Figure 2. Further, embodiments include administering an intravenous dosage initially over a period of 30 minutes to 2 hours. See par. 7.
Ivaturi teaches a mixed dose methods wherein a single IV dose is immediately followed by an oral administration. It is abundantly clear that dose titration is taught and conveys to a POSA that is should be done and appears to be required to be guided through clinical response. As such, if a subjects requires an increase in dosage, they could be administered IV sotalol under QTc monitoring and have their Cmax, ss achieved rapidly to ensure the dose is safe. At that time, they could be transitioned to oral maintenance dosing as taught by Ivaturi. This would impart the benefits taught by Ivaturi to include a shorter hospital stay and a cost savings, among others.
This is particularly the case given the predictability of pharmacokinetic parameters, including Cmax, ss, and Tmax, the known bioavailability of oral compared to IV sotalol, and the known QTc-concentration relationship, among others.
Ivaturi and secondary references cited below explains that the rapid infusion of sotalol is known to be safe. Ivaturi explains that IV infusions as rapid as 5 minutes have been without incident. In examples, Ivaturi teaches administration of an IV infusion of 40 mg, followed by an IV infusion of 20 mg, and followed by an IV infusion of 20 mg. This is an 80 mg infusion, e.g., over a period of 2 hours. Ivaturi explains a goal to accelerate dosing of Cmax, ss to as early as 1 day. In some embodiment, Cmax, ss is achieved within 4 hours of initiation of treatment (i.e., 2 hours after completion of a 2 hour IV regimen) in a method wherein one IV infusion or more are followed by oral administration. See par. 61. In some cases, an oral dose can immediately follow IV administration (i.e., a mixed dosing regimen is also contemplated). In other embodiments, at the end of a 2-hour infusion, an 80 mg dose can be administered followed by another 80 mg 12 hours after the initiation of infusion. Similar achievement for 120 mg and 160 mg oral doses can also be achieved through such regimen. Thus, regardless of the ultimate maintenance dosage desired, the ability administer rapid IV sotalol followed by oral sotalol is predictable. Cmax is known to be a function of length of infusion and dose-proportionate linear pharmacokinetics for sotalol.
Ivaturi teaches a first infusion of 10 mg to 60 mg over 0.5 hours. See prior art claim 4. Then, a second infusion can be over 0.5 hours after the start of the first infusion. This second infusion is 10 to 40 mg. This equates to 100 mg over 1 hour and falls within the scope of the instant claims. Further, a third infusion of 10 mg to 30 mg starting 0.5 hours after the start of the second infusion is claimed. See prior art claims 12 and 13, e.g. Thus, Ivaturi claims administering 100 mg over 1 hour and 130 mg over 1.5 hours. While these administration may not be in a “single” IV dosage, the dosing regimen overlaps. Treatment of naïve patients is also contemplated. See par.’s 44, 47, 49, and others.
It would have been prima facie obvious to a person of ordinary skill in the art prior the filing of the instant application to combine the teachings of Batul, Li, Somberg, Saul, and Ivaturi to arrive at the instantly claimed methods. One would have been motivated to do so because Ivaturi provides a motivation to expeditiously arrive at an oral dosage after IV therapy, and provides a strong correlation to assist a POSA to arrive at a proper dosage in a subject with renal impairment. Dosage must decrease in amount and/or frequency of administrations as renal impairment increases. Further, the claimed dosage baselines are taught. Batul explains that IV sotalol dosage includes administering 1-1.5 mg/kg over 5-30 minutes. In a 30 kg pediatric subject, this would include 30-45 mg over 5-30 minutes, and in a 70 kg human, this would include 70-105 mg over 5-30 minutes. These rates are consistent with the rapid rates of infusion claimed and in some cases are even faster than the rapid infusion rates claimed. Moreover, Batul explicitly states that such rapid IV administration can be used in a hospital setting to transition a subject to oral therapy. Li explains that subjects that are administered IV sotalol and converted to a normal sinus rhythm were transitioned to oral sotalol. For example, patients with atrioventricular reentrant tachycardia who converted to sinus rhythm were transitioned to oral therapy in as few as 3 hours after starting IV sotalol. See p1367, 1st par. Somberg and Saul are cited merely to show the known predictability of sotalol pharmacokinetic data. For example, Cmax is known to be a function of length of infusion, wherein increasing duration of infusion decreases Cmax, and even pediatric patients show a dose-proportionate linear pharmacokinetic profile. As such, as person of ordinary skill in the art would understand how to obtain a desired Cmax by altering length of infusion and dosage, e.g. The prior art shows that the IV and oral dosage equivalents, which for the oral dosage include a range of 80 mg to 160 mg, which is the same range presently claimed. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’" In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Optimizing a dosage of a known-result effective variable with predictable trends in pharmacokinetic parameters would require nothing more than routine experimentation, including in those subjects with varying degrees of renal function, as explicitly taught by Ivaturi.
As such, no claim is allowed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,610,660, in view of Ivaturi (above). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘660 patent include converting a subject from IV to oral sotalol with doses of oral and IV administration that overlap the claimed doses. Further, the doses include a time range that is optimizable and overlaps the timing of oral administration initiation instantly claimed.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,344,518, in view of Ivaturi (above). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘518 patent include converting a subject from IV to oral sotalol with doses of oral and IV administration that overlap the claimed doses. Further, the doses include a time range that is optimizable and overlaps the timing of oral administration initiation instantly claimed.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,512,620, in view of Ivaturi (above). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘620 patent include converting a subject from IV to oral sotalol with doses of oral and IV administration that overlap the claimed doses. Further, the doses include a time range that is optimizable and overlaps the timing of oral administration initiation instantly claimed.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12,403,109, in view of Ivaturi (above). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘109 patent include converting a subject from IV to oral sotalol with doses of oral and IV administration that overlap the claimed doses. Further, the doses include a time range that is optimizable and overlaps the timing of oral administration initiation instantly claimed.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,696,902, in view of Ivaturi (above). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘109 patent include converting a subject from IV to oral sotalol with doses of oral and IV administration that overlap the claimed doses. Further, the doses include a time range that is optimizable and overlaps the timing of oral administration initiation instantly claimed.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,390,431, in view of Ivaturi (above). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘431 patent include converting a subject from IV to oral sotalol with doses of oral and IV administration that overlap the claimed doses. Further, the doses include a time range that is optimizable and overlaps the timing of oral administration initiation instantly claimed.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the following copending Application Numbers in view of Ivaturi (above).
17/306,490 (claims 1-22);
18/417,748 (claims 21-29);
18/322,111 (claims 8-28);
18/126,561 (claims 1-20);
18/107,785 (claims 6-32);
18/135,467 (claims 1-16);
18/304,196 (claims 1-22);
19/019,556 (claims 1, 2, 4-12);
18/631,538 (claims 1-20); and
19/022,878 (claims 1-20).
Although the claims at issue are not identical, they are not patentably distinct claims of the applications cited above because they include an obvious or optimizable dosage range and are directed to converting a subject from IV to oral sotalol with doses of oral and IV administration. Further, the claims take into account renal clear and treat subjects with normal or abnormal renal clearance. In view of the cited prior art, renal clearance can be considered as a known parameter for optimization and a roadmap to arrive at a suitable dosage regimen.
As such, no claim is allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D BARSKY whose telephone number is (571)272-2795. The examiner can normally be reached on 9-5 M-F.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JARED BARSKY/Primary Examiner, Art Unit 1628