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 21, 22, and 24 are pending and examined.
Claim Rejections - 35 USC § 112
Claim 24 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. It is not clear what the phrase “corresponding to an 80 mg oral dose” means. This phrase is interpreted to mean that the IV dose provides an equivalent bioavailability as an oral dose. Further, the phrase “sufficient to achieve a target Cmax” can mean anything. The “target” depends on the desire of the administrator, e.g.
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 21, 22, and 24 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. Typically a subject is required to stay at a hospital for three days prior to discharge and this method of IV to oral transition substantially limits the need for a longer hospital stay. See par. 35. Ivaturi teaches monitoring maximum QTc prolongation and changes in prolongation relative to a baseline measurement.
A patient can be treated if 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. 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.
Pharmacokinetic parameters are predictable, including Cmax, ss, and Tmax, the known bioavailability of oral compared to IV sotalol, and the known QTc-concentration relationship, among others. See Figures.
Ivaturi explains that the rapid infusion of sotalol is known to be safe. 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 embodiments, Cmax and steady state are achieved within 4 hours of initiation of treatment (i.e., 2 hours after completion of a 2 hour IV regimen), which is described in a method wherein at least one IV infusion is 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 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.
Here, Applicant claims an IV dose of about 80 mg prior to 80 mg BID. Ivaturi teaches a an IV dose of 80 mg prior to 160 mg orally. Ivaturi also teaches that if a subject has impaired renal function, they could have their dosage administered less frequently, e.g. For example, “the time between the intravenous dose and the oral dose or between subsequent oral maintenance doses may be lengthened.” See par. 31. Figure 8 shows 80 mg IV followed by 160 mg orally. So, if a less frequent administration could be 160 mg split up over the course of a day as 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.
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 taught to be possible regardless of renal abnormality. More specifically, 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 disclosure was typically a 5 hours infusion, although Ivaturi teaches rapid infusion over 1-3 hours and even over periods of 5 minutes have been shown to be safe. A shorter infusion allows 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 and encompass the approximately 80 mg IV dose followed by 160 mg divided into two doses over the subsequent 24 hours. 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. There is a reasonable and predictable expectation of arriving at the claimed methods in view of Ivaturi because Ivaturi teaches an IV dose of 80 mg prior to 160 mg orally. In view of the claimed moderate renal impairment, a POSA would optimize such dosage by administering a commensurately less frequent administration or extending the time between IV and oral administration, e.g. Rather than administering about 80 mg via IV followed by 160 mg immediately thereafter, Applicant claimed administering about 80 mg via IV followed by 160 mg over the next 24 hours broken into two doses of 80 mg. This appears to be exactly in line with standard dosing and the known optimization based on a subject’s renal function. Absent evidence to the contrary, the claimed dosage appears obvious in view of the cited prior art.
Claims 21, 22, and 24 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.
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215
822
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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.
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568
1546
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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 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. Typically a subject is required to stay at a hospital for three days prior to discharge and this method of IV to oral transition substantially limits the need for a longer hospital stay. See par. 35. Ivaturi teaches monitoring maximum QTc prolongation and changes in prolongation relative to a baseline measurement.
A patient can be treated if 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. 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.
Pharmacokinetic parameters are predictable, including Cmax, ss, and Tmax, the known bioavailability of oral compared to IV sotalol, and the known QTc-concentration relationship, among others. See Figures.
Ivaturi explains that the rapid infusion of sotalol is known to be safe. 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 embodiments, Cmax and steady state are achieved within 4 hours of initiation of treatment (i.e., 2 hours after completion of a 2 hour IV regimen), which is described in a method wherein at least one IV infusion is 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 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.
Here, Applicant claims an IV dose of about 80 mg prior to 80 mg BID. Ivaturi teaches a an IV dose of 80 mg prior to 160 mg orally. Ivaturi also teaches that if a subject has impaired renal function, they could have their dosage administered less frequently, e.g. For example, “the time between the intravenous dose and the oral dose or between subsequent oral maintenance doses may be lengthened.” See par. 31. Figure 8 shows 80 mg IV followed by 160 mg orally. So, if a less frequent administration could be 160 mg split up over the course of a day as 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.
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 21, 22, and 24 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 21, 22, and 24 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 21, 22, and 24 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 21, 22, and 24 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 21, 22, and 24 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 21, 22, and 24 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 21, 22, and 24 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);
18/324,703 (claims 1-18);
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.
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/JARED BARSKY/Primary Examiner, Art Unit 1628