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 .
DETAILED ACTION
Claims 1, 8-24, 26 and 29 are pending in the application. Claims 1, 8-24, 26 and 29 are rejected. Claims 12-15, 17-19 and 22 are objected to.
Priority
This application is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/US2022/023003, filed on April 1, 2022, which claims benefit of Provisional Application No. 63/169,998, filed on April 2, 2021.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) filed on April 23, 2024, August 13, 2025 and September 4, 2025 are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached.
Claim Objections
Claim 12-15, 17-19 and 22 are objected to because of the following informalities:
Claims 12-15 and 17-19 should be amended to include the word -the- before the word “administering” for sake of clarity.
Claim 22 should be amended to replace “is selected from sodium chloride” with -is selected from the group consisting of sodium chloride- for sake of clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. § 112(b):
(b) CONCLUSION — The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. § 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
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.
The term “associated” as recited in claim 24 is a relative term which renders the claim indefinite. The term “associated” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As noted in MPEP § 2173, “The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent.” Applicant may amend claim 24 to clearly indicate what constitutes an association between a “prefilled polymeric cartridge” and an “on-body wearable delivery device.”
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.
Claims 1, 8, 9-11, 13, 20-22, 24, 26 and 29 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by CDER Clinical Review (www.accessdata.fda.gov/drugsatfda_docs/nda/2023/209988Orig1s000MedR.pdf; accessed online March 9, 2026) as evidenced by FUROSCIX Data Sheet (www.accessdata.fda.gov/drugsatfda_docs/label/2025/209988s003lbl.pdf; retrieved online March 9, 2026).
Regarding claims 1, 8, 9-11, 13, 20-22, 24, 26 and 29, the CDER Clinical Review teaches that the FUROSCIX® infusor “is a device-drug combination product that was designed to deliver a fixed dose (80mg) of subcutaneous furosemide to edematous patients who are unresponsive to oral diuretics.” See e.g., page 11. The FUROSCIX® infusor drug device combination product, as taught in the CDER Clinical Review, consists of “a proprietary subcutaneous delivery system, the Infusor” and an injectable furosemide “[s]olution for subcutaneous administration” at a “8 mg/mL, 80 mg one time dose” (i.e., 80 mg per 10 mL) contained in a prefilled 10 mL Crystal Zenith® (i.e., polymer) cartridge. See e.g., Introduction and page 1.
The term “about” as present in the limitation “about 80 mg furosemide over a period...” refers to “a ±10% variation from the nominal value unless otherwise indicated or inferred from the context.” See page 8 of instant specification. Accordingly, a person of ordinary skill would recognize that “about 80 mg furosemide” as recited in instant claims 1, 8, 11 and 13 would correspond to furosemide being administered in a range from 72-88 mg. With respect to administration time periods, the CDER Clinical Review teaches “[o]f the total 80 mg dose of Furoscix, 30 mg was [] administered subcutaneously over the first hour followed by 12.5 mg/hour over the subsequent 4 hours.” See e.g., page 36. Therefore, based on the CDER Clinical Review, administering FUROSCIX® over 4 hours and 59 min (i.e., less than 5 hours) would result in a furosemide dose of 79.79 mg. Accordingly, the prior art teaches 79.79 mg of furosemide (i.e., “about 80 mg furosemide” as instantly claimed) administered in 4 hours and 59 minutes (i.e., “less than 5 hours” as instantly claimed) which reads on the instant requirements of claims 1, 8, 11 and 13.
Regarding instant claims 8, 11 and 26, the “results in” statement in each claim is considered to be drawn towards characteristics that would necessarily be present from employing the instantly claimed methods and is, therefore, considered to be non-limiting. “[W]hen considering a prior art method, the anticipation doctrine examines the natural and inherent results in that method without regard to the full recognition of those benefits or characteristics within the art field at the time of the prior art disclosure.” Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377-78 (Fed. Cir. 2005). “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP § 2112.01(II).
Regarding instant claim 20, FUROSCIX®, as taught in the CDER Clinical Review, is known to be a liquid pharmaceutical formulation containing a pharmaceutically acceptable buffer, such as water for injection, as evidenced by the attached FUROSCIX® data sheet. See e.g., page 10.
Regarding instant claim 21, FUROSCIX®, as taught in the CDER Clinical Review, is known to have a pH of 7.4, as evidenced by the attached FUROSCIX® data sheet. See e.g., page 10.
Regarding instant claim 22, FUROSCIX®, as taught in the CDER Clinical Review, is known to contain pharmaceutically acceptable excipients, such as sodium chloride and sodium hydroxide, as evidenced by the attached FUROSCIX® data sheet. See e.g., page 10.
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.
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 12, 14-19 and 23 are rejected under 35 U.S.C. § 103 as being unpatentable over CDER Clinical Review (www.accessdata.fda.gov/drugsatfda_docs/nda/2023/209988Orig1s000MedR.pdf; accessed online March 9, 2026).
Determining the scope and contents of the prior art (See MPEP § 2141.01)
The prior art teaches that the FUROSCIX® infusor “is a device-drug combination product that was designed to deliver a fixed dose (80mg) of subcutaneous furosemide to edematous patients who are unresponsive to oral diuretics.” See e.g., page 11. The FUROSCIX® infusor drug-device combination product, as taught in the CDER Clinical Review, consists of “a proprietary subcutaneous delivery system, the Infusor” and an injectable furosemide “[s]olution for subcutaneous administration” at a “8 mg/mL, 80 mg one time dose” (i.e., 80 mg per 10 mL) contained in a prefilled 10 mL Crystal Zenith® (i.e., polymer) cartridge. See e.g., Introduction and page 1.
Ascertainment of the differences between the prior art and the claims (See MPEP § 2141.02)
Regarding instant claims 12 and 14-19, the CDER Clinical Review does not teach the instantly claimed dosage periods and delivery profiles (i.e., continuous). However, it does teach a “total 80 mg dose of Furoscix, 30 mg was [] administered subcutaneously over the first hour followed by 12.5 mg/hour over the subsequent 4 hours.” See e.g., page 36. The CDER Clinical Review also teaches a “preprogrammed bi-phasic 5-hour subcutaneous drug administration.” See e.g., page 36. Note that the “results in” expression recited in claim 16 is considered to be drawn towards characteristics that would necessarily be present from employing the “bi-phasic delivery profile” as recited in parent claim 15 and is, therefore, considered to be non-limiting. “[W]hen considering a prior art method, the anticipation doctrine examines the natural and inherent results in that method without regard to the full recognition of those benefits or characteristics within the art field at the time of the prior art disclosure.” Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377-78 (Fed. Cir. 2005). “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP § 2112.01(II).
Regarding instant claim 23, the CDER Clinical Review does not explicitly teach an “isosmotic” pharmaceutical formulation. However, it does teach the drug-device combination FUROSCIX® which contains a furosemide formulation for subcutaneous infusion.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 12 and 14-19, it would, therefore, have been obvious to a person of ordinary skill in the art to arrive at the instantly claimed dosage periods and delivery profiles based on the teachings of the CDER Clinical Review. It is within the ability of a skilled artisan to experiment with various dosage periods and delivery profiles for any given pharmaceutical compound being administered to a patient population. “It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.” In re Williams, 36 F.2d 436, 438 (CCPA 1929). As the optimization of result-effective variables, i.e., variables that achieve a recognized result, such as dosage periods and delivery profiles are considered to be within the ability of the skilled artisan, the skilled artisan would be motivated to optimize the prior art dosage periods and delivery profiles as part of the routine optimization process. “[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).
Regarding instant claim 23, it would have been obvious for a person of ordinary skill in the art to arrive at an isosmotic formulation of furosemide based on the teachings of the CDER Clinical Review. The instant specification states that the term “‘isosmotic’ refers to a solution or a formulation that has the same or similar concentration of solutes as found in bodily fluids.” See pages 9 and 10. Therefore, it would be expected that the prior art FUROSCIX® designed to deliver a furosemide formulation via subcutaneous infusion would contain a furosemide formulation having the same or similar concentration of solutes as found in bodily fluids to prevent tissue damage and ensure safe absorption of furosemide into the body.
Conclusion
No claims are allowed.
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/D.M.S./Examiner, Art Unit 1626
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626