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 .
Priority
This application is a U.S. national stage patent application under 35 U.S.C. § 371 of
International Application No. PCT/US2021/044723, filed on August 5, 2021, which claims the benefit of, and priority to, U.S. Provisional Application No. 63/061,518, filed on August 5, 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/03/2026 has been considered by the examiner.
Claims status
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on April 03, 2026. Claims 1, 10-11, 16-18, 20-24, 26-29, and 31-32 are pending and under examination. Claims 2-9, 12-15, 19, 25, and 30 are cancelled.
Action Summary
Claims 1, 10-11, 16-18, 24, 26, and 29 rejected under 35 U.S.C. 103 as being unpatentable over Sica et al (Jacc Basic to Translational Science Vol. 3, No. 1, February 2018, pages 25-34) in view of Frederick Furness (ONdrugDelivery Issue No 97, May 13th, 2019) and Michaels et al (US9,884,039 B2), are maintained, but modified in light of the claim amendment.
Claims 20-23 rejected under 35 U.S.C. 103 as being unpatentable over Sica et al (Jacc Basic to Translational Science Vol. 3, No. 1, February 2018, pages 25-34) in view of Frederick Furness (ONdrugDelivery Issue No 97, May 13th, 2019) and Michaels et al (US9,884,039 B2) as applied to claims 1, 10-11, 16-18, 24, 26, 29, in further view of American Reagent Inc (Furosemide injection, USP, 10 mg/ml label, published online on February 16, 2017 by Wayback machine), are maintained.
Claims 27 and 28 rejected under 35 U.S.C. 103 as being unpatentable over Sica et al (Jacc Basic to Translational Science Vol. 3, No. 1, February 2018, pages 25-34) in view of Frederick Furness (ONdrugDelivery Issue No 97, May 13th, 2019) and Michaels et al (US9,884,039 B2) as applied to claims 1, 10-11, 16-18, 24, 26, and 29, in further view of Goulding et al (Can J Crit Care Nurs. 2015 Winter;26(4):23-7), are maintained.
Claims 31 and 32 rejected under 35 U.S.C. 103 as being unpatentable over Michaels et al (US9,884,039 B2) in view of Sica et al (Jacc Basic to Translational Science Vol. 3, No. 1, February 2018, pages 25-34) in view of Frederick Furness (ONdrugDelivery Issue No 97, May 13th, 2019), are maintained.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 10-11, 16-18, 24, 26, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Sica et al (Jacc Basic to Translational Science Vol. 3, No. 1, February 2018, pages 25-34) in view of Frederick Furness (ONdrugDelivery Issue No 97, May 13th, 2019) and Michaels et al (US9,884,039 B2).
Sica discloses a method of treating fluid overload in congestive heart failure comprising a buffered subcutaneously infusion liquid formulation comprising 30 mg furosemide in hour 1 followed by 12.5 mg/h for 4 h at a pH 7.4 using a wearable patch pump. (See the Highlights Section of page 26). Sica teaches parenteral diuretics form the cornerstone of decongestion in heart failure. (See Summary Section.) Moreover, Sica teaches the subcutaneous furosemide formulation consists of furosemide reconstituted in a buffered solution containing tromethamine at a physiological pH of approximately 7.4 (range 7.2 to 7.6). Following SC administration, therapeutic levels of furosemide were reached within 30 min and maintained for up to 6 h. This resulted in complete bioavailability and equivalent diuresis when compared with 80 mg of intravenous furosemide. (See last paragraph of the right column of page 27) The buffer solution taught by Sica contemplates water. Sica further teaches the subject is an adult. (See Table 1.) Lastly Sica teaches the adult patient has a NYHA class II. However, due to some overlap between class II and class III, the patient taught by Sica can reasonably encompasses both classes II and III heart failure.
Sica does not teach a single-use prefilled polymeric cartridge. Moreover, Sica does not teach tromethamine hydrochloride in the amount of 89 mg and is isosmotic.
Frederick Furness teaches traditional methods of SC drug delivery include autoinjectors and infusion pumps. These delivery regimens have traditionally been limited by the volume which can be delivered. (See third paragraph of the middle column of page 41.) Moreover, Frederick Furness teaches in the drive to formulate biologics for patient adherence, higher volumes and higher viscosities are typical product profiles of many SC drugs. However, higher viscosities may not allow for conventional delivery due to the need for longer injection times to reduce patient discomfort. West recognized this trend and responded by developing its SmartDose® drug delivery platform, which includes a first-generation device that allows up to 3.5 mL of liquid drug to be administered over a longer period. (See last paragraph of the right column of page 35.) Frederick Furness also teaches the second generation SmartDose® 10 mL device had a well-received on-body size and was intuitive, easy to use and desirable. The second-generation SmartDose® 10 mL device was voted the most preferable treatment that allows for monthly dosing, compared with the other treatment options, which included weekly autoinjectors, monthly dosing via multiple autoinjectors, visiting a clinic or via infusion. Patients don’t like taking frequent injections and a second generation SmartDose® 10 mL device monthly injection helped them with less frequent injections (See last paragraph of the right column of page 36.) Monthly dosing is considered a single dose. The smartdose device as wearable device contains preloaded options and large volume and a (See page first paragraph of the left column of page 36 bridging last paragraph of the left column of page 37.) Preloaded meets the limitation of prefilled. Lastly, Frederick Furness teaches the SmartDose® drug as a delivery system for delivery of FUROSCIX® (furosemide) for the treatment of oedema in patients with heart failure. (See first paragraph of the left column of page 37.)
Michaels teaches a method of treating a patient with or exhibiting the symptoms of edema, hypertension or heart failure, the method comprising: administering to a patient a liquid pharmaceutical formulation, wherein the liquid pharmaceutical formulation comprises: furosemide, or a pharmaceutically acceptable salt, hydrate or ester thereof, wherein furosemide is the sole therapeutically active agent in the liquid pharmaceutical formulation and the amount of furosemide in the liquid pharmaceutical formulation is between about 2 mg/mL to about 15 mg/mL; and a pharmaceutically acceptable buffer comprising tris(hydroxymethyl)aminomethane, wherein the concentration of tris(hydroxymethyl)aminomethane in the liquid pharmaceutical formulation is in a range of about 50 mM to about 250 mM; wherein the liquid pharmaceutical formulation is isosmotic and has a pH between about 7.2 to about 8, and the molar ratio of tris(hydroxymethyl)aminomethane to furosemide is greater than or equal to two. (See claim 1.) tris(hydroxymethyl)aminomethane is the same as tromethamine. Moreover, Michaels teaches the administering comprises administering subcutaneously the pharmaceutical formulation. (See claim 2.) A particular preference was given on a liquid pharmaceutical composition consisting of 8 mg/ml furosemide and 50 nM tris buffer at pH 7.0 to 8.0. (See Example 5.) Converting mM to mg/ml: mg/ml = mM x Molecular weight (g/mol)/1000; 50 mM X 157.60 (MW of tromethamine hydrochloride)/1000 = 7.9 mg/ml. Therefore, the 50nM amounts to 7.9 g/ml. Furthermore, Michaels teaches water was used to prepare the Tris buffer. (See lines 50-65 of column 14.)
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It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to modify the method taught by Sica by including congestion due to fluid overload and by substituting the wearable patch pump with the smartdose® taught by Frederick Furness that comprises a preloaded (prefilled) polymeric cartridge (Daikyo Crystal Zenith® polymer cartridge) and by substituting the tromethamine taught by Sica with trometamine hydrochloride taught by Madhu and Michaels to give Applicant’s claimed invention. One would have been motivated to do so, because Sica teaches parenteral diuretics form the cornerstone of decongestion in heart failure and fluid overload in heart failure and because Frederick Furness teaches pumps and other devices are limited by their small volume where said limitation can be overcome by the use of a Smartdose® device containing a preloaded polymeric cartridge comprising furosemide and that can utilize a large volume of 10 ml and because Michaels teaches trometamine hydrochloride can be used as a buffer in the amount of 7.9 mg/ml to prepare 8 mg/ml furosemide. The 7.9 mg/ml Tris and 8 mg/ml furesemide for the total volume of 10 mg of the smartdoce® device result in 79 mg Tris Hcl and 80 mg furosemide. One would reasonably expect the method to minimize frequent administration and easy to use and desirable and to treat congestion due to fluid overload with success.
With respect to the plasma concentration, Sica expressly teaches a plasma concentration of about 1470 ng/mL at one hour following administration of the same 80 mg subcutaneous furosemide regimen delivered as 30 mg during the first hour followed by 12.5 mg/hour for four additional hours, which falls within the claimed range of about 1200 ng/mL to about 1850 ng/mL.
Claims 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Sica et al (Jacc Basic to Translational Science Vol. 3, No. 1, February 2018, pages 25-34) in view of Frederick Furness (ONdrugDelivery Issue No 97, May 13th, 2019) and Michaels et al (US9,884,039 B2) as applied to claims 1, 10-11, 16-18, 24, 26, 29, in further view of American Reagent Inc (Furosemide injection, USP, 10 mg/ml label, published online on February 16, 2017 by Wayback machine).
The teachings of Sica, Frederick Furness, and Michaels have been discussed in the rejection set forth above.
Sica, Frederick Furness, and Michaels collectively do not teach one or more pharmaceutically acceptable excipient in this case sodium chloride.
American Reagent Inc. teaches furosemide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Furosemide Injection 10 mg/mL is a sterile, non-pyrogenic solution in vials for intravenous and intramuscular injection. Each mL contains: Furosemide 10 mg, Water for Injection q.s., Sodium Chloride for isotonicity, Sodium Hydroxide. (See first few paragraphs of the left column.)
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to include sodium chloride as a pharmaceutically acceptable excipient as taught by American Reagent Inc into the method taught by Sica, Frederick Furness, and Michaels to give Applicant’s claimed invention. One would have been motivated to do so, because American Reagent Inc. teaches furosemide Injection 10 mg/mL is a sterile, non-pyrogenic solution in vials for intravenous and intramuscular injection and each mL contains furosemide 10 mg, Water for Injection q.s., Sodium Chloride for isotonicity, Sodium Hydroxide. One would reasonably expect the inclusion of sodium chloride as an isotonic agent to match the osmotic pressure of body fluids, preventing cell damage and ensuring patient comfort.
Claims 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Sica et al (Jacc Basic to Translational Science Vol. 3, No. 1, February 2018, pages 25-34) in view of Frederick Furness (ONdrugDelivery Issue No 97, May 13th, 2019) and Michaels et al (US9,884,039 B2) as applied to claims 1, 10-11, 16-18, 24, 26, and 29, in further view of Goulding et al (Can J Crit Care Nurs. 2015 Winter;26(4):23-7).
The teachings of Sica, Frederick Furness, and Michaels have been discussed in the rejection set forth above.
Sica, Frederick Furness, and Michaels collectively do not teach alerting and visualizing not all of the total volume of 10 ml; of the liquid formulation was delivered from the prefilled polymeric cartridge.
Goulding teaches most intravenous medication errors occur during administration. Smart pumps can reduce the incidence of dose or rate errors using soft and hard limits. However, industry standard dose error reduction software misses errors that occur during titration. The dose change alert was developed to detect errors during titration. (See Abstract.)
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to modify the smartdose® delivery system by including into the program an alert that allows the user or the patient to visualize not all of the total volume of 10 ml; of the liquid formulation was delivered from the prefilled polymeric cartridge to give Applicant’s claimed invention. The motivation to do so is taught by Goulding. One would reasonably expect the smartdose® delivery system to reduce the incidence of the dose or rate errors and improve patient compliance.
Claims 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Michaels et al (US9,884,039 B2) in view of Sica et al (Jacc Basic to Translational Science Vol. 3, No. 1, February 2018, pages 25-34) in view of Frederick Furness (ONdrugDelivery Issue No 97, May 13th, 2019).
Michaels teaches a method of treating a patient with or exhibiting the symptoms of edema, hypertension or heart failure, the method comprising: administering to a patient a liquid pharmaceutical formulation, wherein the liquid pharmaceutical formulation comprises: furosemide, or a pharmaceutically acceptable salt, hydrate or ester thereof, wherein furosemide is the sole therapeutically active agent in the liquid pharmaceutical formulation and the amount of furosemide in the liquid pharmaceutical formulation is between about 2 mg/mL to about 15 mg/mL; and a pharmaceutically acceptable buffer comprising tris(hydroxymethyl)aminomethane, wherein the concentration of tris(hydroxymethyl)aminomethane in the liquid pharmaceutical formulation is in a range of about 50 mM to about 250 mM; wherein the liquid pharmaceutical formulation is isosmotic and has a pH between about 7.2 to about 8, and the molar ratio of tris(hydroxymethyl)aminomethane to furosemide is greater than or equal to two. (See claim 1.) tris(hydroxymethyl)aminomethane is the same as tromethamine. Moreover, Michaels teaches the administering comprises administering subcutaneously the pharmaceutical formulation. (See claim 2.) A particular preference was given on a liquid pharmaceutical composition consisting of 8 mg/ml furosemide and 50 nM tris buffer at pH 7.0 to 8.0. (See Example 5.) Converting mM to mg/ml: mg/ml = mM x Molecular weight (g/mol)/1000; 50 mM X 157.60 (MW of tromethamine hydrochloride)/1000 = 7.9 mg/ml. Therefore, the 50nM amounts to 7.9 g/ml. Additionally, Michaels teaches a number of devices have been proposed to facilitate self - administration of a pharmaceutical formulation. The device typically includes a reservoir containing for example pre-loaded with the pharmaceutical formulation to be administered. (See lines 32-36 of column 12.) Pre-loaded reads on pre-filled. The medical device can be for a single use. (See lines 4-6 of column 13.) Furthermore, Michaels teaches water and sodium hydroxide/sodium hydrochloride were used to prepare the Tris buffer. (See lines 50-65 of column 14.)
Michaels does not teach a volume of 10 ml.
Frederick Furness teaches traditional methods of SC drug delivery include autoinjectors and infusion pumps. These delivery regimens have traditionally been limited by the volume which can be delivered. (See third paragraph of the middle column of page 41.) Moreover, Frederick Furness teaches in the drive to formulate biologics for patient adherence, higher volumes and higher viscosities are typical product profiles of many SC drugs. However, higher viscosities may not allow for conventional delivery due to the need for longer injection times to reduce patient discomfort. West recognized this trend and responded by developing its SmartDose® drug delivery platform, which includes a first-generation device that allows up to 3.5 mL of liquid drug to be administered over a longer period. (See last paragraph of the right column of page 35.) Frederick Furness also teaches the second generation SmartDose® 10 mL device had a well-received on-body size and was intuitive, easy to use and desirable. The second-generation SmartDose® 10 mL device was voted the most preferable treatment that allows for monthly dosing, compared with the other treatment options, which included weekly autoinjectors, monthly dosing via multiple autoinjectors, visiting a clinic or via infusion. Patients don’t like taking frequent injections and a second generation SmartDose® 10 mL device monthly injection helped them with less frequent injections (See last paragraph of the right column of page 36.) Monthly dosing is considered a single dose. The smartdose device a preloaded (prefilled) polymeric cartridge (Daikyo Crystal Zenith® polymer cartridge) as wearable device contains preloaded options and large volume. (See page first paragraph of the left column of page 36 bridging last paragraph of the left column of page 37.) Preloaded meets the limitation of prefilled. Lastly, Frederick Furness teaches the SmartDose® drug as a delivery system for delivery of FUROSCIX® (furosemide) for the treatment of oedema in patients with heart failure. (See first paragraph of the left column of page 37.)
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It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to modify the method taught by Michaels by substituting the medical reservoir taught by Michaels with the smartdose® taught by Frederick Furness that comprises a preloaded (prefilled) polymeric cartridge (Daikyo Crystal Zenith® polymer cartridge) comprising furosemide and that can utilize a large volume of 10 ml to give Applicant’s claimed invention. One would have been motivated to do so, because Frederick Furness teaches pumps and other devices are limited by their small volume where said limitation can be overcome by the use of a smartdoce® device containing a preloaded polymeric cartridge comprising furosemide and that can utilize a large volume of 10 ml. One would reasonably expect the substitution to successfully give a single-use polymeric prefilled cartridge that can be associated with an on- body wearable delivery device using a five-hour bi-phasic delivery profile (Smartdose®) for administering subcutaneously a liquid pharmaceutical formulation to an adult human.
Acknowledgement is made of the receipt and entry of Applicant’s arguments/remarks filed on April 03, 2026.
Applicant argues that Sica does not teach or suggest an isostomic formulation containing 79 mg of Tris Hcl in a single-use polymeric cartridge and that Sica does not teach loading the formulation into an on-body wearable delivery device using a prefilled cartridge.
Applicant’s argument is not persuasive. The rejection does not rely on Sica alone for all claimed limitations. Rather, Sica is relied upon for teaching the core method of treating fluid overload in heart failure using an 80 mg subcutaneous furosemide regimen administered over five hours according to a biphasic delivery profile of 30 mg during the first hour followed by 12.5 mg/hour for the subsequent four hours. Sica also teaches a buffered furosemide formulation containing tromethamine at a physiological pH of about 7.4. While Sica does not expressly use the term “isosmotic,” Michaels expressly teaches a liquid pharmaceutical formulation comprising furosemide and TRIS, wherein the liquid pharmaceutical formulation is isosmotic and has a pH between 7.2 and about 8.0. Michaels further expressly teaches both the claimed isosmotic property and the claimed tromethamine concentration. Michaels is also relied upon for teaching an isosmotic furosemide formulation comprising Tris/tromethamine buffer, including 8 mg/mL furosemide and 50 nM tris buffer (tris-Hcl). As previously explained, 50 mN tromethamine hydrochloride corresponds to about 7.9 mg/mL, which in a 10 mL formulation corresponds to about 79 mg. Furness is relied upon for teaching the SmartDose 10 mL on-body delivery system including a prefilled syringe cartridge suitable for subcutaneous delivery of Foroscix/furosemide. Thus, the claimed formulation, amount of tromethamine hydrochloride, 10 ML volume, single-use prefilled cartridge, and on-body wearable delivery device are taught or suggested by the references in combination.
Applicant argues that the claimed pharmacokinetic profile and urine/sodium excretion profile are not taught or suggested by the cited references.
In response, Applicant’s argument is not persuasive. Sica expressly reports plasma furosemide concentrations obtained after administration of substantially the same 80 mg subcutaneous furosemide regimen. Sica reports that following subcutaneous administration, the plasma furosemide concentration at one hour as about 1,470 ng/mL, which falls within the claimed range of about 1,200 ng/mL to about 1,850 ng/mL after the first hour of administration. Sica further teaches the therapeutic levels of furosemide of at least 1,000 ng/mL were maintained following subcutaneous administration. Because the five-hour infusion is complete at about five-hours, Sica’s teaching that therapeutic levels were maintained through about six hours reasonably teaches or suggest the claimed concentration of about 1,000 ng/mL about one hour after administration is complete.
Applicant’s sodium-excretion argument is also not persuasive. The claims recite “one or more of the following,” such that the prior art needs only teach or suggest at least one of the listed pharmacokinetic/pharmacodynamic alternatives. In the present case, the plasma concentration forms the basis for the modified/updated rejection.
Applicant argues that Furness does not cure the deficiencies of Sica because Furness does not disclose the particular formulation or pharmacokinetic profile.
In response, Applicant’s argument is not persuasive because Furness is not relied upon for the furosemide formulation or plasma concentration profile. Sica and Michaels teach or suggest the furosemide formulation and administration regimen, while Furness is relied upon for the on-body wearable delivery device, SmartDose 10 ml platform, and single-use prefilled polymeric cartridge. A reference needs not teach all claim limitations when the rejection is based on the combination of references. Furness provides the device-related teachings that Sica lacks, and one of ordinary skill in the art would have been expected to use the SmartDose 10 mL on-body delivery platform to administer the 10 mL furosemide regimen taught by Sica/Michaels because Furness identifies SmartDose as a suitable platform for subcutaneous delivery of Foroscix/furosemide and teaches that the device addresses the need for larger volume subcutaneous administration over an extended period.
Applicant argues that Michaels teaches the formulation but does not teach administering it in a single-use prefilled cartridge over five-hours to produce the claimed plasma concentrations.
In response, Applicant’s argument is not persuasive. Michaels is not relied upon for the five-hour biphasic regimen or plasma concentration data. Sica teaches the five-hour biphasic 80 mg subcutaneous furosemide regimen and expressly reports plasma concentrations that fail within the claimed ranges. Michaels is relied upon for the isosmotic formulation and tris/tromethamine buffer teachings. Furness is relied upon for the pre-filled cartridge and on-body delivery device. The rejection therefore properly relies on the collective teachings of Sica, Michaels, and Furness.
With respect to claims 20-23. Applicant argues that American Regent is an intravenous furosemide label and that a skilled artisan would not necessarily use sodium chloride or sodium hydroxide from an intravenous formulation in a subcutaneous formulation.
In response, Applicant’s argument is not persuasive. American Regent is relied upon only to show that sodium chloride and sodium hydroxide were known pharmaceutical acceptable excipients for furosemide injectable formulations, including sodium chloride for tonicity adjustment and sodium hydroxide for pH adjustment. Sica and Michaels already establish the suitability of buffered furosemide formulations for parenteral administration, including subcutaneous administration at physiological pH. The use of sodium chloride to adjust tonicity and sodium hydroxide/hydrochloric acid to adjust pH would have been routine formulation practice, particularly where the claims broadly recite these materials as pharmaceutically acceptable excipients. One would have had a reasonably expectation of success in including such excipients in the formulation taught by Sica and Michaels to obtain acceptable tonicity and pH for the parenteral formulation.
With respect to claims 27 and 28, Applicant argues that Goulding does not teach alerting an adult human when the total volume is not administered doing the five-hour delivery profile.
In response, Applicant’s argument is not persuasive. Goulding is relied upon to show that smart-pump systems were known to provide alerts to reduce administration errors. Furness teaches on-body SmartDose delivery device with user feedback features, and the claimed alerting/visualizing limitations relates to notifying the user when the intended volume has not been delivered. One of ordinary skill in the art would reasonably expect the incorporate alerting or visual feedback into the SmartDose-base delivery system to notify the user or patient of incomplete delivery, because doing so would reduce dose-administration error and improve safe use of the device. The claimed alerting feature is therefore a predictable use of known smart-pump feedback/alert function in a known drug-delivery system.
With respect to claims 31 and 32, Applicant argues that none of the cited references could predict that the claimed five-hour biphasic delivery profile using the claimed formulation would result in the recited therapeutic plasma concentrations.
In response, Applicant’s argument is not persuasive. Claim 31 is directed to a single-use prefilled cartridge comprising the liquid pharmaceutical formulation and configured for use with an on-body wearable delivery device using a five-biphasic delivery profile. Sica expressly teaches the five-hour biphasic 80 mg subcutaneous furosemide regimen and reports plasma concentration resulting from that regimen. Michaels teaches the isosmotic furosemide formulation containing tris/tromethamine buffer in amounts corresponding the claimed formulation. Furness teaches the SmartDose 10 mL on-body delivery system and prefilled polymeric cartridge for delivery of Furoscix/frusemide. Thus, the cited cartridge is rendered obvious by the combination of Michaels, Sica, and Furness. Applicant’s argument improperly attacks the reference individually rather than addressing the combined teachings of the references.
Conclusion
Claims 1, 10-11, 16-18, 20-24, 26-29, and 31-32 are not allowed.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
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/JEAN P CORNET/Primary Examiner, Art Unit 1628
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