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 .
Response to Amendments
Applicant’s amendments to the claims of April 27, 2026, in response to the Office Action of October 27, 2025 are acknowledged.
Response to Arguments
Applicant’s filing of a Terminal Disclaimer on April 27, 2026, and the Office’s approval are acknowledged. As such, the Double Patenting Rejections are withdrawn.
Ivaturi teaches treating subjects that are sotalol naïve and those that have different levels of kidney function. A dose adjustment roadmap is set forth in Ivaturi. Assessing a subject for their QTc is taught to make sure that the subject does not deviate more than 20% from a baseline. Further, many of the examples provides by Ivaturi teach administering a IV dose and then following up with a oral dose that is approximately twice the IV dose. This is approximately what has been claimed. For example, Figure 8 provides for dose titration examples in sotalol naïve subjects in which 80 mg is administered intravenously followed by 160 mg orally. The distinction is that the 80 mg IV dose is administered in the example over about 2 hours rather than 1 hour. However, the prior art provides for much safer and rapid infusions. As noted in paragraph 34, administrations as rapid as 5 minutes are considered safe.
Applicant argues that there is no motivation to administered sotalol to a renally impaired subjects.
The examiner notes that Ivaturi teaches administration to subjects with normal or abnormal renal function. Additionally, the claimed level of renal function of 60 mL/min is on the threshold of normal and minimally impairment renal function, as evidenced by Santopinto et al., “Creatinine clearance and adverse hospital outcomes in patients with acute coronary syndromes: findings from the global registry of acute coronary events (GRACE),” Heart, 2003 Sep;89(9):1003-1008. Santopinto indicates that >60 ml/min is normal to minimal impairment and 30-60 is minimal to moderate dysfunction. Thus, a level of 60 includes minimal impairment.
Applicant argues that it is error to compare Ivaturi’s target oral dose of 160 mg to the claimed 80 mg twice daily regimen.
The examiner notes that the instant claims provide for administration of a IV dose of approximately 80 mg and subsequently administering an oral dose of 80 mg twice daily to yield an oral administration of 160 mg daily. One example of dosage optimization provided by Ivaturi includes a maintenance dose of 80 mg every 12 hours, such that the sotalol concentration reaches 800 ng/ml every 12 hours. See par. 56.
Prior art claims 8 and 9 provide for 30 mg administered by IV 0.5 hours after the start of the first infusion. If a first infusion is up to 60 mg over 0.5 hours per claim 4, this provides for a total of up to 90 mg over the first hour for a subject with abnormal renal function. Further, claim 17 depends from claim 7 and provides for an 80 mg oral dose administered every 12 hours. While the subject in claim 17 has normal renal function, the instantly claimed subject is borderline mild impairment/normal. Further, claim 18 provides for an oral dose to a subject with renal impairment to include 80 mg every 24 hours. Thus, it would appear that if a subject is borderline renal impairment or mild renal impairment, they could receive an oral dose of sotalol that is in the range of 80 mg every 12-24 hours after infusion. Claim 6 provides for starting an oral dose shortly after IV infusion, wherein the subject has abnormal renal function. The claimed methods are hardly distinct over the teachings of the prior art. No allegation of a critical concentration or other unexpected result has been alleged and shown.
Applicant argues that there is no motivation to exceed Ivaturi’s dose for renally impairment patients and patients with normal renal function.
The methods claimed provide for administration that includes 82.5-85 mg over about 1 hour and 80 mg twice daily thereafter. As noted above in the prior art, a dose adjustment can be made, but is not required for renal impairment. This is described in paragraph 31 to include an option to decrease amount or strength of IV dose and/or decrease the time between oral doses and the strength of those doses to adjust when necessary. Further, faster and slower doses are considered safe and a CrCl of 60 ml/min is normal/minimally impaired. A level of 61 ml/min, e.g., is considered minimal impairment and would not necessarily require a dose adjustment initially. Ivaturi notes that renal impairment between 40 and 60 CrCl is mild impairment and 60 is the highest functioning of that category. See par. 51. Ivaturi also indicates that dosing for sotalol naïve patients includes analyzing the methods of Figure 4, e.g. A concentration QTc relationship is established as well as a relationship among dosage and established steady state. See Figures 2 and 3. A concentration of a sotalol 80 mg BID regimen is shown in Figure 2. Figure 4 describes those dosing regimens to explore for sotalol naïve patients and this includes a 80 mg loading dose.
Applicant argues that the claimed method should not be compared to that of Ivaturi because the claimed method administers 160 mg orally at one time, which provides a different Cmax.
The examiner notes that 160 mg orally could be adjusted to account for abnormal renal function and this can include lengthening the time between subsequent oral doses. See par. 31. This could mean that rather than administering 160 mg at one time, 80 mg doses are separated by 12 hours. This would be a decrease in strength and is taught by the prior art.
Further, the examiner notes that paragraph 58 describes a scenario in which 80 mg is administered via IV over 2 hours. Then, 160 mg dose can be administered. If, e.g., renal impairment requires an adjustment, it is conceivable that a once daily 160 mg dose would be broken into 80 mg doses separated by 12 hours.
The ability to transition subjects from IV to oral sotalol, including naïve and renally impaired subjects is taught. A general roadmap is provided to make sure that such administration accounts for all levels of renal impairment. Further, IV and oral doses, including maintenance dosing are taught to include the same doses claimed including about 80 mg, 120 mg, and 160 mg. Dosage optimization techniques are provided and are relatively unlimited. Further, the safety of more rapid IV infusions is well-established. Moreover, the PK and relationship of dose and QTc as well as dose and serum concentrations (i.e., ss Cmax) are recognized. The roadmap/trend in how to optimize doses is well-established.
As such, no claim is allowed.
Status of the Claims
Claims 21, 22, and 30-40 are pending and examined.
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 30-40 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 30-40 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.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 Monday through Friday from 8:30 to 5:30. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Amy L. 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
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