DETAILED ACTION
Status of Application
The response filed 05/27/2026 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claims 1, 6, 11, 25-26 have been amended.
Claims 1-2, 4-11, 25-26 are pending in the case.
Claims 1-2, 4-11, 25-26 are present for examination.
Applicant had previously elected Group I.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
All grounds not addressed in the action are withdrawn as a result of amendment.
New grounds of rejection are set forth in the current office action as a result of amendment.
New Grounds of Rejection
Due to the amendment of the claims the new grounds of rejection are applied:
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4-6, 10 are rejected under 35 U.S.C. 103 as being unpatentable over Di Schiena (U.S. Pat. 4698361) in view of The Pharmaceutics and Compounding Laboratory (Guidelines, Equipment, and Supplies for Sterile Compounding –Physiological pH).
Rejection:
Di Schiena teaches that furosemide is known to be used as a diuretic and antihypertensive drug (i.e. treating hypertension) and teaches that furosemide as a tris(hydroxymethyl)aminomethane salt (Furotris, trometamol salt of furosemide) is particularly suitable for parenteral administration like intravenous (abstract, Col. 1 line 1-32, claim 4 and 6). Di Schiena also teaches that Furotris is presents with furosemide and trometamol at a molar ratio of about 1:1 (example 1-2). Example 4 present a sterile solution of 33.3g Furotris with 1000ml of distilled water suitable for injection (solution has tris at about 73.74 mM (33.3g Furotris is about 8.93g tris in 1000ml, and 24.37g furosemide/1000ml=24.34mg/ml (falling within the breath of about 30mg/ml), see full document specifically areas cited).
Di Schiena does not expressly teach the pH of the parenteral composition but does teach it for parenteral administration such as intravenous.
The Pharmaceutics and Compounding Laboratory teaches that the physiological pH is known to be about 7.4 and an effort should be made to provide formulations that do not vary significantly from that pH.
Wherein it is would be obvious before the effective filing date of the claimed invention to formulate the pH of the parenteral composition to be at physiological pH as suggested by The Pharmaceutics and Compounding Laboratory and produce the claimed invention; as Di Schiena teaches parenteral administration of furotris wherein it is prima facie obvious to utilize the known desired physiological pH (7.4) for parenteral forms with a reasonable expectation of success.
Response to Arguments:
Applicant’s arguments with respect to the previous prior art rejections of Ranade in view of Somberg have been considered but are moot due to the claim amendments and the new rejection applied as a result of claim amendments.
Accordingly, the rejection stands.
Claims 2, 7, 25 are rejected under 35 U.S.C. 103 as being unpatentable over Di Schiena (U.S. Pat. 4698361) in view of The Pharmaceutics and Compounding Laboratory (Guidelines, Equipment, and Supplies for Sterile Compounding –Physiological pH) as applied to claims 1, 4-6, 10 above, further in view of Beringer et al. (Parenteral Preparations -Overview of Unique Characteristics of Parenteral Dosage Forms, Added Substances, Route of Administration).
Rejection:
The teachings of Di Schiena in view of The Pharmaceutics and Compounding Laboratory are addressed above.
Di Schiena in view of The Pharmaceutics and Compounding Laboratory does not expressly teach the tonicity/osmolarity of the parenteral composition or subcutaneous administration but does teach it for parenteral administration.
Beringer et al. teaches that it is known that parenteral forms should be isotonic (isosmotic, Page 802 first column last paragraph fourth bullet), that substances are added to make a solution isotonic or near physiological pH to provide patient comfort by reducing pain and issue irritation (Added Substances, Page 803 second bullet, Page 804 tonicity agents), and known routes of parenteral injection includes subcutaneous (Page 804 d=second column first paragraph).
Wherein it is would be obvious before the effective filing date of the claimed invention to utilize subcutaneous injection and formulate the tonicity to physiological isotonic levels as suggested by Beringer et al. and produce the claimed invention; as Di Schiena teaches parenteral administration of furotris wherein it is prima facie obvious to utilize the known desired isotonicity for parenteral forms with a reasonable expectation of success and a known form of parenteral administration including subcutaneous with a reasonable expectation of success absent evidence of criticality for the claimed means.
Claims 8-9, 11, 26 are rejected under 35 U.S.C. 103 as being unpatentable over Di Schiena (U.S. Pat. 4698361) in view of The Pharmaceutics and Compounding Laboratory (Guidelines, Equipment, and Supplies for Sterile Compounding –Physiological pH) and Beringer et al. (Parenteral Preparations -Overview of Unique Characteristics of Parenteral Dosage Forms, Added Substances, Route of Administration) as applied to claims 2, 7, 25 above, further in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
Rejection:
The teachings of Di Schiena in view of The Pharmaceutics and Compounding Laboratory and Beringer et al. are addressed above; including using furosemide as a diuretic and antihypertensive drug (i.e. treating hypertension) and that furosemide is a tris(hydroxymethyl)aminomethane salt (Furotris, trometamol salt of furosemide) for parenteral administration like subcutaneous administration with excipients like tonicity/osmotic agents at isotonic levels and physiological pH of about 7.4.
Di Schiena in view of The Pharmaceutics and Compounding Laboratory and Beringer et al. does not expressly teach the patch/pump means of subcutaneous administration but does teach parenteral administration including subcutaneous administration.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4-9, 11, 25-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12370168.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are to the same method with the same components in values and limitations that fall within the breath of the instant claims wherein they are obvious over the instant claims, and as the patented claims recite the liquid formulation to be isoosmotic wherein it implicitly has osmotic agents to attain the isoosmotic state. With regards to instant claim 6 and 11, it is also prima facie obvious to optimize within the patented range to attain the desired therapeutic profile and arrive at the claimed furosemide concentration absent evidence of criticality for the claimed value.
Response to Arguments:
Applicant asked for the rejection to be held in abeyance. There is no terminal disclaimer.
Accordingly, the rejection stands.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12370168 as applied to claims 1-2, 4-9, 11, 25-26 above, in view of www.pharmacorama.com
(Routes of drug administration - Parenteral route).
The teachings of patented claims are addressed above. The patented claims does not expressly teach the intravenous administration of furosemide but does recite treating conditions like hypertension with furosemide at 5mg/ml or more.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of administration such as parenteral administration like intravenous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
Response to Arguments:
Applicant asked for the rejection to be held in abeyance. There is no terminal disclaimer.
Accordingly, the rejection stands.
Claims 11, 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 12370168 in view of www.infusionnurse.org (Is there a difference? Osmolarity VS. Osmolality).
The patented claim recites the same instant claimed method with the same components in ranges falling within the instant claimed values.
www.infusionnurse.org teaches that infused solutions be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
Response to Arguments:
Applicant asked for the rejection to be held in abeyance. There is no terminal disclaimer.
Accordingly, the rejection stands.
Claims 1-2, 4-9, 11, 25-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11433044.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are to the same method with the same components in values and limitations that fall within the breath of the instant claims wherein they are obvious over the instant claims, and as the patented claims recite the liquid formulation to be isoosmotic wherein it implicitly has osmotic agents to attain the isoosmotic state. With regards to instant claim 6 and 11, it is also prima facie obvious to optimize within the patented range including the patented values i.e. about 20mg/ml or greater, about 25mg/ml or greater) to attain the desired therapeutic profile and arrive at the claimed furosemide concentration absent evidence of criticality for the claimed value.
Response to Arguments:
Applicant asked for the rejection to be held in abeyance. There is no terminal disclaimer.
Accordingly, the rejection stands.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11433044 as applied to claims 1-2, 4-9, 11, 25-26 above, in view of www.pharmacorama.com
(Routes of drug administration - Parenteral route).
The teachings of patented claims are addressed above. The patented claims does not expressly teach the intravenous administration of furosemide but does recite treating conditions like hypertension with furosemide at 5mg/ml or more.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of administration such as parenteral administration like intravenous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
Response to Arguments:
Applicant asked for the rejection to be held in abeyance. There is no terminal disclaimer.
Accordingly, the rejection stands.
Claims 1-2, 4-10, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 9884039.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are to the same method with the same components in values and limitations that fall within the breath of the instant claims wherein they are obvious over the instant claims, and as the patented claims recite the liquid formulation to be isoosmotic wherein it implicitly has osmotic agents to attain the isoosmotic state. The range of furosemide in patented claim 11 is to about 2-about 20mg/ml which falls within the range of instant claim 1 and overlaps in breath with instant claim 11 of about 30mg/ml wherein eve a slight overlap establishes a prima facie case of obviousness.
Response to Arguments:
Applicant asked for the rejection to be held in abeyance. There is no terminal disclaimer.
Accordingly, the rejection stands.
Claims 11 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-23 of U.S. Patent No. 9884039 in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The patented claims recite the same method with the same components of the instant claims and the amount of furosemide in the patented claims overlaps those of the instant claims (e.g. 25mg/ml is an overlapping value as it is embraced by the patented range and the instant claimed range) wherein even a slight overlap in ranges establishes a prima facie case of obviousness. The patented claims recite subcutaneous administration and pump device.
The patented claims do not recite a patch for subcutaneous administration but does recite subcutaneous administration and pump device.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
Response to Arguments:
Applicant asked for the rejection to be held in abeyance. There is no terminal disclaimer.
Accordingly, the rejection stands.
Claims 1, 4-6, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of U.S. Patent No. 12491195.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite limitations that fall within the breath of the instant claims and the amount of furosemide in the patented claims that fall within the claimed values and pH range that embraces the instant claimed range wherein it is prima facie obvious to optimize within the patented range and arrive at the claimed pH values with a reasonable expectation of success absent evidence of criticality for the claimed values. The patented amount of furosemide overlaps the dependent instant claim 6 (bottom end of range of about 40mg/ml e.g. 35mg/ml overlaps about 30mg/ml which embraces 35mg/ml) wherein even a slight overlap in values establishes a prima facie case of obviousness.
Response to Arguments:
Applicant’s arguments center on the assertion the patented claims are to about 40mg/ml-about 250mg/ml furosemide and about 25mM-about 100mM Tris and about 0.1-about 30% benzyl alcohol wherein the skilled artisan would not be motivated by the higher furosemide concentration and benzyl alcohol formulation in the patent to arrive at the instant claimed formulations that are for lower levels of furosemide. This is fully considered but not persuasive. Contrary to Applicant’s assertion the instant claims recite the furosemide to be about 5mg/ml or greater wherein there is no upper limit for the amount of furosemide and the amount of furosemide in the patented claims fall within the instant claimed range. The claims are also open language wherein it is open to the inclusion of other components.
Accordingly, the rejection stands.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of U.S. Patent No. 12491195 as applied to claims 1, 4-6, 25 above, in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the patented claim are addressed above.
The patented claim does not expressly teach the isoosmolarity of the administered composition, but does teach the liquid composition for administration.
www.infusionnurse.org teaches that solutions to be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
Response to Arguments:
Applicant’s arguments are those presented to the amount of furosemide in the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 7, 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of U.S. Patent No. 12491195 as applied to claims 1, 4-6, 25 above, in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of patented claim are addressed above.
The patented claims does not expressly teach the intravenous or subcutaneous administration of furosemide but does recite treating conditions like hypertension and edema with furosemide at 5mg/ml or more.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of administration such as parenteral administration like intravenous and subcutaneous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
Response to Arguments:
Applicant’s arguments are those presented to the amount of furosemide in the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of U.S. Patent No. 12491195 in view of www.pharmacorama.com (Routes of drug administration - Parenteral route) as applied to claims 7, 10 above, further in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of patented claim in view of www.pharmacorama.com are addressed above.
The patented claim in view of www.pharmacorama.com does not expressly teach the patch/pump means of subcutaneous administration but does teach parenteral administration including subcutaneous.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
Response to Arguments:
Applicant’s arguments are those presented to the amount of furosemide in the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 1, 4-6, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of U.S. Patent No. 12491195 in view of The Pharmaceutics and Compounding Laboratory (Guidelines, Equipment, and Supplies for Sterile Compounding –Physiological pH).
The patented claim recite limitations that fall within the breath of the instant claims and the amount of furosemide in the patented claims that fall within the claimed values. The patented amount of furosemide overlaps the dependent instant claim 6 (bottom end of range of about 40mg/ml e.g. 35mg/ml overlaps about 30mg/ml which embraces 35mg/ml) wherein even a slight overlap in values establishes a prima facie case of obviousness.
The patented claim does not recite the pH range but does teach the method with the same furosemide and tromethamine.
The Pharmaceutics and Compounding Laboratory teaches that the physiological pH is known to be about 7.4 and an effort should be made to provide formulations that do not vary significantly from that pH.
Wherein it is would be obvious before the effective filing date of the claimed invention to formulate the pH of the parenteral composition to be at physiological pH as suggested by The Pharmaceutics and Compounding Laboratory and produce the claimed invention; as Di Schiena teaches parenteral administration of furotris wherein it is prima facie obvious to utilize the known desired physiological pH (7.4) with a reasonable expectation of success.
Response to Arguments:
Applicant’s arguments center on the assertion the patented claims are to about 40mg/ml-about 250mg/ml furosemide and about 25mM-about 100mM Tris and about 0.1-about 10% benzyl alcohol wherein the skilled artisan would not be motivated by the higher furosemide concentration and benzyl alcohol formulation in the patent to arrive at the instant claimed formulations that are for lower levels of furosemide. This is fully considered but not persuasive. Contrary to Applicant’s assertion the instant claims recite the furosemide to be about 5mg/ml or greater wherein there is no upper limit for the amount of furosemide and the amount of furosemide in the patented claims fall within the instant claimed range. The claims are also open language wherein it is open to the inclusion of other components.
Accordingly, the rejection stands.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of U.S. Patent No. 12491195 in view of The Pharmaceutics and Compounding Laboratory (Guidelines, Equipment, and Supplies for Sterile Compounding –Physiological pH) as applied to claims 1, 4-6, 25, further in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the patented claim in view of The Pharmaceutics and Compounding Laboratory are addressed above.
The patented claim in view of The Pharmaceutics and Compounding Laboratory does not expressly teach the isoosmolarity of the administered composition, but does teach the liquid composition for administration.
www.infusionnurse.org teaches that solutions to be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
Response to Arguments:
Applicant’s arguments are those presented to the amount of furosemide in the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 7, 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of U.S. Patent No. 12491195 in view of The Pharmaceutics and Compounding Laboratory (Guidelines, Equipment, and Supplies for Sterile Compounding –Physiological pH) as applied to claims 1, 4-6, 25 above, further in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of patented claim in view of The Pharmaceutics and Compounding Laboratory are addressed above.
The patented claim in view of The Pharmaceutics and Compounding Laboratory does not expressly teach the intravenous or subcutaneous administration of furosemide but does recite treating conditions like hypertension and edema with furosemide at 5mg/ml or more.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of administration such as parenteral administration like intravenous and subcutaneous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
Response to Arguments:
Applicant’s arguments are those presented to the amount of furosemide in the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of U.S. Patent No. 12491195 in view of The Pharmaceutics and Compounding Laboratory (Guidelines, Equipment, and Supplies for Sterile Compounding –Physiological pH) and www.pharmacorama.com (Routes of drug administration - Parenteral route) as applied to claims 7, 10 above, further in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of patented claim in view of The Pharmaceutics and Compounding Laboratory and www.pharmacorama.com are addressed above.
The patented claim in view of The Pharmaceutics and Compounding Laboratory and www.pharmacorama.com does not expressly teach the patch/pump means of subcutaneous administration but does teach parenteral administration including subcutaneous.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
Response to Arguments:
Applicant’s arguments are those presented to the amount of furosemide in the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 1, 4-6, 7, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-13 of U.S. Patent No. 11998555.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite limitations that fall within the breath of the instant claims and the amount of furosemide in the patented claims that fall within the claimed values and pH range that embraces the instant claimed range wherein it is prima facie obvious to optimize within the patented range and arrive at the claimed pH values with a reasonable expectation of success absent evidence of criticality for the claimed values. The patented amount of furosemide overlaps the dependent instant claim 6 (bottom end of range of about 40mg/ml e.g. 35mg/ml overlaps about 30mg/ml which embraces 35mg/ml) wherein even a slight overlap in values establishes a prima facie case of obviousness.
Response to Arguments:
Applicant’s arguments center on the assertion the patented claims are to greater than about 40mg/ml furosemide and about 25mM-about 100mM Tris and about 0.1-about 10% benzyl alcohol wherein the skilled artisan would not be motivated by the higher furosemide concentration and benzyl alcohol formulation in the patent to arrive at the instant claimed formulations that are for lower levels of furosemide. This is fully considered but not persuasive. Contrary to Applicant’s assertion the instant claims recite the furosemide to be about 5mg/ml or greater wherein there is no upper limit for the amount of furosemide and the amount of furosemide in the patented claims fall within the instant claimed range. The claims are also open language wherein it is open to the inclusion of other components.
Accordingly, the rejection stands.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-13 of U.S. Patent No. 11998555 as applied to claims 1, 4-5, 7, 25 above, in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the patented claims are addressed above.
The patented claims does not expressly teach the isoosmolarity of the administered composition, but does teach the liquid composition for administration.
www.infusionnurse.org teaches that solutions to be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
Response to Arguments:
Applicant’s arguments are those presented to the amount of furosemide in the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-13 of U.S. Patent No. 11998555 as applied to claims 1, 4-5, 7, 25 above, in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the patch/pump means of subcutaneous administration but does teach subcutaneous administration including subcutaneous.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
Response to Arguments:
Applicant’s arguments are those presented to the amount of furosemide in the patented claims which are addressed above.
Accordingly, the rejection stands.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-13 of U.S. Patent No. 11998555 as applied to claims 1, 4-5, 7, 25 above, in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the intravenous administration of furosemide but does recite treating conditions like hypertension and edema with furosemide at from about 40mg/ml or more and subcutaneous administration.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of parenteral administration such as intravenous instead of subcutaneous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
Response to Arguments:
Applicant’s arguments are those presented to the amount of furosemide in the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 1, 4-5, 7, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-8 of U.S. Patent No. 12048709.
It is appreciated that Applicant noted that there was a typographical error and the patent was 12048709 and not the typographical error of 12042709. The typographical error has been corrected above.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite limitations that fall within the breath of the instant claims and the amount of furosemide in the patented claims that fall within the claimed values and pH range amount of furosemide embraces the instant claimed range wherein it is prima facie obvious to optimize within the patented range and arrive at the claimed pH values and amount of furosemide with a reasonable expectation of success absent evidence of criticality for the claimed values.
Response to Arguments:
Applicant’s arguments center on the assertion the patented claims are to about 60mg/ml-about 250mg/ml furosemide and about 25mM-about 150mM Tris and about 0.1-about 30% benzyl alcohol wherein the skilled artisan would not be motivated by the higher furosemide concentration and benzyl alcohol formulation in the patent to arrive at the instant claimed formulations that are for lower levels of furosemide. This is fully considered but not persuasive. Contrary to Applicant’s assertion the instant claims recite the furosemide to be about 5mg/ml or greater wherein there is no upper limit for the amount of furosemide and the amount of furosemide in the patented claims fall within the instant claimed range. The claims are also open language wherein it is open to the inclusion of other components.
Accordingly, the rejection stands.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-8 of U.S. Patent No. 12048709 as applied to claims 1, 4-5, 7, 25 above, in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the patented claims are addressed above.
The patented claims does not expressly teach the isoosmolarity of the administered composition, but does teach the liquid composition for administration.
www.infusionnurse.org teaches that solutions to be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
Response to Arguments:
Applicant’s arguments are those presented to the amount of furosemide in the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-8 of U.S. Patent No. 12048709 as applied to claims 1, 4-5, 7, 25 above, in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the patch/pump means of subcutaneous administration but does teach subcutaneous administration including subcutaneous.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
Response to Arguments:
Applicant’s arguments are those presented to the amount of furosemide in the patented claims which are addressed above.
Accordingly, the rejection stands.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-8 of U.S. Patent No. 12048709 as applied to claims 1, 4-5, 7, 25 above, in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the intravenous administration of furosemide but does recite treating conditions like hypertension and edema with furosemide at from about 40mg/ml or more and subcutaneous administration.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of parenteral administration such as intravenous instead of subcutaneous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
Response to Arguments:
Applicant’s arguments are those presented to the amount of furosemide in the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 1, 4-8, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-17 of U.S. Patent No. 12491193 in view of The Pharmaceutics and Compounding Laboratory (Guidelines, Equipment, and Supplies for Sterile Compounding –Physiological pH).
The patented claim recite limitations that fall within the breath of the instant claims and the amount of furosemide in the patented claims that fall within the claimed values. The patented amount of furosemide overlaps the dependent instant claim 6 (bottom end of range of about 40mg/ml e.g. 35mg/ml overlaps about 30mg/ml which embraces 35mg/ml) wherein even a slight overlap in values establishes a prima facie case of obviousness
The patented claim does not recite the pH range but does teach the method with the same furosemide and tromethamine.
The Pharmaceutics and Compounding Laboratory teaches that the physiological pH is known to be about 7.4 and an effort should be made to provide formulations that do not vary significantly from that pH.
Wherein it is would be obvious before the effective filing date of the claimed invention to formulate the pH of the parenteral composition to be at physiological pH as suggested by The Pharmaceutics and Compounding Laboratory and produce the claimed invention; as Di Schiena teaches parenteral administration of furotris wherein it is prima facie obvious to utilize the known desired physiological pH (7.4) with a reasonable expectation of success.
Response to Arguments:
Applicant’s arguments center on the assertion the patented claims are to about 40mg/ml-about 250mg/ml furosemide and about 25mM-about 100mM Tris and benzyl alcohol wherein the skilled artisan would not be motivated by the higher furosemide concentration and benzyl alcohol formulation in the patent to arrive at the instant claimed formulations that are for lower levels of furosemide, and that Somberg teaches furosemide in combination with metolazone.
This is fully considered but not persuasive. Contrary to Applicant’s assertion the instant claims recite the furosemide to be about 5mg/ml or greater wherein there is no upper limit for the amount of furosemide and the amount of furosemide in the patented claims fall within the instant claimed range. The claims are also open language wherein it is open to the inclusion of other components. The arguments to Somberg are moot as addressed by the new rejection above as a result of claim amendment.
Accordingly, the rejection stands.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-17 of U.S. Patent No. 12491193 in view of The Pharmaceutics and Compounding Laboratory (Guidelines, Equipment, and Supplies for Sterile Compounding –Physiological pH) as applied to claims 1, 4-8, 25, further in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the patented claim in view of The Pharmaceutics and Compounding Laboratory are addressed above.
The patented claim in view of The Pharmaceutics and Compounding Laboratory does not expressly teach the isoosmolarity of the administered composition, but does teach the liquid composition for administration.
www.infusionnurse.org teaches that solutions to be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
Response to Arguments:
Applicant’s arguments are those presented to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-17 of U.S. Patent No. 12491193 in view of The Pharmaceutics and Compounding Laboratory (Guidelines, Equipment, and Supplies for Sterile Compounding –Physiological pH) as applied to claims 1, 4-8, 25 above, further in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of patented claim in view of The Pharmaceutics and Compounding Laboratory are addressed above.
The patented claim in view of The Pharmaceutics and Compounding Laboratory does not expressly teach the patch/pump means of subcutaneous administration but does teach subcutaneous administration.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
Response to Arguments:
Applicant’s arguments are those presented to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over 14-17 of U.S. Patent No. 12491193 in view of The Pharmaceutics and Compounding Laboratory (Guidelines, Equipment, and Supplies for Sterile Compounding –Physiological pH) as applied to claims 1, 4-5, 7-8, 25 above, further in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of patented claim in view of The Pharmaceutics and Compounding Laboratory are addressed above.
The patented claim in view of The Pharmaceutics and Compounding Laboratory does not expressly teach the intravenous administration of furosemide but does recite treating conditions like hypertension and edema with furosemide such as with subcutaneous administration.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of parenteral administration like intravenous rather than subcutaneous with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
Response to Arguments:
Applicant’s arguments are those presented to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 1, 4-7, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-6 of U.S. Patent No. 12491194.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite limitations that fall within the breath of the instant claims and the amount of furosemide in the patented claims that fall within the claimed values and pH range amount of furosemide embraces the instant claimed range wherein it is prima facie obvious to optimize within the patented range and arrive at the claimed pH values and amount of furosemide with a reasonable expectation of success absent evidence of criticality for the claimed values. The patented amount of furosemide overlaps the dependent instant claim 6 (bottom end of range of about 40mg/ml e.g. 35mg/ml overlaps about 30mg/ml which embraces 35mg/ml) wherein even a slight overlap in values establishes a prima facie case of obviousness.
Response to Arguments:
Applicant’s arguments center on the assertion the patented claims are to about 40mg/ml-about 250mg/ml furosemide and about 25mM-about 100mM Tris and about 0.1-about 30% benzyl alcohol wherein the skilled artisan would not be motivated by the higher furosemide concentration and benzyl alcohol formulation in the patent to arrive at the instant claimed formulations that are for lower levels of furosemide.
This is fully considered but not persuasive. Contrary to Applicant’s assertion the instant claims recite the furosemide to be about 5mg/ml or greater wherein there is no upper limit for the amount of furosemide and the amount of furosemide in the patented claims fall within the instant claimed range. The claims are also open language wherein it is open to the inclusion of other components.
Accordingly, the rejection stands.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-6 of U.S. Patent No. 12491194 as applied to claims 1, 4-7, 25 above, in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the patented claims are addressed above.
The patented claims does not expressly teach the isoosmolarity of the administered composition, but does teach the liquid composition for administration.
www.infusionnurse.org teaches that solutions to be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
Response to Arguments:
Applicant’s arguments are those presented to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-6 of U.S. Patent No. 12491194 as applied to claims 1, 4-7, 25 above, in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the patch/pump means of subcutaneous administration but does teach subcutaneous administration including subcutaneous.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
Response to Arguments:
Applicant’s arguments are those presented to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-6 of U.S. Patent No. 12491194 as applied to claims 1, 4-7, 25 above, in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the intravenous administration of furosemide but does recite treating conditions like hypertension and edema with furosemide at from about 40mg/ml or more and subcutaneous administration.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of parenteral administration such as intravenous instead of subcutaneous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
Response to Arguments:
Applicant’s arguments are those presented to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 1, 4-5, 7, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-5 of U.S. Patent No. 12491196.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite limitations that fall within the breath of the instant claims and the amount of furosemide in the patented claims that fall within the claimed values and pH range amount of furosemide embraces the instant claimed range wherein it is prima facie obvious to optimize within the patented range and arrive at the claimed pH values and amount of furosemide with a reasonable expectation of success absent evidence of criticality for the claimed values.
Response to Arguments:
Applicant’s arguments center on the assertion the patented claims are to about 60mg/ml-about 250mg/ml furosemide and about 25mM-about 100mM Tris and about 0.1-about 10% benzyl alcohol wherein the skilled artisan would not be motivated by the higher furosemide concentration and benzyl alcohol formulation in the patent to arrive at the instant claimed formulations that are for lower levels of furosemide.
This is fully considered but not persuasive. Contrary to Applicant’s assertion the instant claims recite the furosemide to be about 5mg/ml or greater wherein there is no upper limit for the amount of furosemide and the amount of furosemide in the patented claims fall within the instant claimed range. The claims are also open language wherein it is open to the inclusion of other components.
Accordingly, the rejection stands.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-5 of U.S. Patent No. 12491196 as applied to claims 1, 4-7, 25 above, in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the patented claims are addressed above.
The patented claims does not expressly teach the isoosmolarity of the administered composition, but does teach the liquid composition for administration.
www.infusionnurse.org teaches that solutions to be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
Response to Arguments:
Applicant’s arguments are those presented to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-5 of U.S. Patent No. 12491196 as applied to claims 1, 4-7, 25 above, in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the patch/pump means of subcutaneous administration but does teach subcutaneous administration including subcutaneous.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
Response to Arguments:
Applicant’s arguments are those presented to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-5 of U.S. Patent No. 12491196 as applied to claims 1, 4-7, 25 above, in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the intravenous administration of furosemide but does recite treating conditions like hypertension and edema with furosemide at from about 40mg/ml or more and subcutaneous administration.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of parenteral administration such as intravenous instead of subcutaneous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
Response to Arguments:
Applicant’s arguments are those presented to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 1, 4-5, 7, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-21 of U.S. Patent No. 12491196.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite limitations that fall within the breath of the instant claims and the amount of furosemide in the patented claims that fall within the claimed values and pH range amount of furosemide embraces the instant claimed range wherein it is prima facie obvious to optimize within the patented range and arrive at the claimed pH values and amount of furosemide with a reasonable expectation of success absent evidence of criticality for the claimed values.
Response to Arguments:
Applicant’s arguments center on the assertion the patented claims are to about 40mg/ml-about 250mg/ml furosemide and about 50mM-about 150mM Tris and about 0.5-about 5% benzyl alcohol wherein the skilled artisan would not be motivated by the higher furosemide concentration and benzyl alcohol formulation in the patent to arrive at the instant claimed formulations that are for lower levels of furosemide. It is noted that the amount of furosemide in the patented claims is about 80mg/ml.
This is fully considered but not persuasive. Contrary to Applicant’s assertion the instant claims recite the furosemide to be about 5mg/ml or greater wherein there is no upper limit for the amount of furosemide and the amount of furosemide in the patented claims fall within the instant claimed range. The claims are also open language wherein it is open to the inclusion of other components.
Accordingly, the rejection stands.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-21 of U.S. Patent No. 12491196 as applied to claims 1, 4-5, 7, 25 above, in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the patented claims are addressed above.
The patented claims does not expressly teach the isoosmolarity of the administered composition, but does teach the liquid composition for administration.
www.infusionnurse.org teaches that solutions to be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
Response to Arguments:
Applicant’s arguments are those presented to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-21 of U.S. Patent No. 12491196 as applied to claims 1, 4-5, 7, 25 above, in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the patch/pump means of subcutaneous administration but does teach subcutaneous administration including subcutaneous.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
Response to Arguments:
Applicant’s arguments are those presented to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-21 of U.S. Patent No. 12491196 as applied to claims 1, 4-5, 7, 25 above, in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the intravenous administration of furosemide but does recite treating conditions like hypertension and edema with furosemide at from about 40mg/ml or more and subcutaneous administration.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of parenteral administration such as intravenous instead of subcutaneous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
Response to Arguments:
Applicant’s arguments are those presented to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 1, 4-5, 7, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-7, 19-20 of U.S. Patent No. 12491197.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite limitations that fall within the breath of the instant claims and the amount of furosemide in the patented claims that fall within the claimed values and pH range amount of furosemide embraces the instant claimed range wherein it is prima facie obvious to optimize within the patented range and arrive at the claimed pH values and amount of furosemide with a reasonable expectation of success absent evidence of criticality for the claimed values.
Response to Arguments:
Applicant’s arguments center on the assertion the patented claims are to about 60mg/ml-about 250mg/ml furosemide (or about 80mg/ml) and about 25mM-about 150mM Tris and about 0.1-about 10% benzyl alcohol wherein the skilled artisan would not be motivated by the higher furosemide concentration and benzyl alcohol formulation in the patent to arrive at the instant claimed formulations that are for lower levels of furosemide. It is noted that the amount of furosemide in the patented claims 19-20 is about 80mg/ml.
This is fully considered but not persuasive. Contrary to Applicant’s assertion the instant claims recite the furosemide to be about 5mg/ml or greater wherein there is no upper limit for the amount of furosemide and the amount of furosemide in the patented claims fall within the instant claimed range. The claims are also open language wherein it is open to the inclusion of other components.
Accordingly, the rejection stands.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-7, 19-20 of U.S. Patent No. 12491197 as applied to claims 1, 4-5, 7, 25 above, in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the patented claims are addressed above.
The patented claims does not expressly teach the isoosmolarity of the administered composition, but does teach the liquid composition for administration.
www.infusionnurse.org teaches that solutions to be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
Response to Arguments:
Applicant’s arguments are those presented to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-7, 19-20 of U.S. Patent No. 12491197 as applied to claims 1, 4-5, 7, 25 above, in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the patch/pump means of subcutaneous administration but does teach subcutaneous administration including subcutaneous.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
Response to Arguments:
Applicant’s arguments are those presented to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-7, 19-20 of U.S. Patent No. 12491197 as applied to claims 1, 4-5, 7, 25 above, in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the intravenous administration of furosemide but does recite treating conditions like hypertension and edema with furosemide at from about 40mg/ml or more and subcutaneous administration.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of parenteral administration such as intravenous instead of subcutaneous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
Response to Arguments:
Applicant’s arguments are those presented to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 1, 4-6, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-26 of U.S. Patent No. 12403120.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite limitations that fall within the breath of the instant claims and the amount of furosemide in the patented claims that fall within the claimed values (about 10mg/ml-about 30mg/ml, about 60mM-about 95mM=about 19.8mg/ml-about 31mg/ml) and the pH and tris range either fall within the instant ranges or overlaps them wherein even a slight overlap in ranges establishes a prima facie case of obviousness with a reasonable expectation of success absent evidence of criticality for the claimed values.
Response to Arguments:
Applicant’s arguments center on the assertion the patented claims are to about 10mg/ml-about 30mg/ml furosemide and less than or equal to 40mM Tris with a molar ratio of Tris to furosemide of 0.8 or less, and the instant claims with about 5mg/ml or more (i.e. 15mM furosemide) and about 25mM Tris can have a ratio of Tris to furosemide as high as 1.67 where the patented claim do not teach having more Tris than furosemide.
This is fully considered but not persuasive. Contrary to Applicant’s assertion the patented claims have furosemide from about 10-about 30mg/ml furosemide (about 10mg/ml-about 30mg/ml= about 30mM-about 90mM furosemide with 40mM or less of Tris wherein when the molar ratio of Tris to furosemide is 0.8 of less (i.e. 40mM Tris/90mM furosemide, 20mM Tris/30mM furosemide); the values falls within the instant claims as optimization of the patented range to attain the patent ratio is prima facie obvious with a reasonable expectation of success absent evidence of criticality for the claimed values. Patented claims 24-26 do not recite a molar ratio wherein the argument is not persuasive.
Accordingly, the rejection stands.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-26 of U.S. Patent No. 12403120 as applied to claims 1, 4-6, 25 above, in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the patented claims are addressed above.
The patented claims does not expressly teach the isoosmolarity of the administered composition, but does teach the liquid composition for administration.
www.infusionnurse.org teaches that solutions to be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
Response to Arguments:
Applicant’s arguments are those presented to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 7 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-26 of U.S. Patent No. 12403120 as applied to claims 1, 4-6, 25 above, in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the intravenous or subcutaneous administration of furosemide but does recite treating conditions like hypertension and heart failure with furosemide in a liquid composition.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of parenteral administration such as intravenous and subcutaneous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
Response to Arguments:
Applicant’s arguments are those presented to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-26 of U.S. Patent No. 12403120 in view of www.pharmacorama.com (Routes of drug administration - Parenteral route) as applied to claims 7 and 10 above, further in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of patented claims in view of www.pharmacorama.com are addressed above.
The patented claims in view of www.pharmacorama.comdoes not expressly teach the patch/pump means of subcutaneous administration but does teach subcutaneous administration including subcutaneous.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
Response to Arguments:
Applicant’s arguments are those presented to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 11, 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-26 of U.S. Patent No. 12403120 in view of www.pharmacorama.com (Routes of drug administration - Parenteral route) and Caffey et al. (U.S. Pat. Pub. 2011/0060280) as applied to claims 8-9 above, further in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the patented claims in view of www.pharmacorama.com and Caffey et al are addressed above.
The patented claims in view of www.pharmacorama.com and Caffey et al does not expressly teach the isoosmolarity of the administered composition, but does teach the liquid composition for subcutaneous administration with a patch.
www.infusionnurse.org teaches that solutions to be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
Response to Arguments:
Applicant’s arguments are those presented to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 1, 4-6, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 28 of U.S. Patent No. 11246851.
Although the claim at issue are not identical, they are not patentably distinct from each other because the patented claims recite limitations that fall within the breath of the instant claims and the amount of furosemide and tris in the patented claims that fall within the claimed values (about 20mg/ml-about 40mg/ml furosemide, about 25mM Tris) and the pH either is the same range or embraces it wherein optimization within the pH range to attain the desired therapeutic profile is a prima facie case of obviousness with a reasonable expectation of success absent evidence of criticality for the claimed values.
Response to Arguments:
Applicant’s arguments center on the assertion the patented claims are to about 20mg/ml-about 40mg/ml furosemide and about 25mM Tris and about 10-about 40% sulfobutyl ether beta cyclodextrin wherein the skilled artisan would not be motivated by the higher furosemide concentration in the patent to arrive at the instant claimed formulations that are for lower levels of furosemide, and the assertion that the ratio of Tris to furosemide claimed is lower than what can be present in the instant claims.
This is fully considered but not persuasive. Contrary to Applicant’s assertion the instant claims recite the furosemide to be about 5mg/ml or greater wherein there is no upper limit for the amount of furosemide and the amount of furosemide in the patented claim fall within the instant claimed range; and the patent claim does not require a ratio of Tris to furosemide as asserted
Accordingly, the rejection stands.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 28 of U.S. Patent No. 11246851 as applied to claims 1, 4-6, 25 above, in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the patented claim are addressed above.
The patented claim does not expressly teach the isoosmolarity of the administered composition, but does teach the liquid composition for administration.
www.infusionnurse.org teaches that solutions to be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
Response to Arguments:
Applicant’s arguments are those presented to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 7 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 28 of U.S. Patent No. 11246851 as applied to claims 1, 4-6, 25 above, in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of patented claim are addressed above.
The patented claim does not expressly teach the intravenous or subcutaneous administration of furosemide but does recite treating conditions like hypertension and heart failure with furosemide in a liquid composition.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of parenteral administration such as intravenous and subcutaneous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
Response to Arguments:
Applicant’s arguments are those presented to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 28 of U.S. Patent No. 11246851 in view of www.pharmacorama.com (Routes of drug administration - Parenteral route) as applied to claims 7 and 10 above, further in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of patented claim in view of www.pharmacorama.com are addressed above.
The patented claim in view of www.pharmacorama.comdoes not expressly teach the patch/pump means of subcutaneous administration but does teach subcutaneous administration including subcutaneous.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
Response to Arguments:
Applicant’s arguments are those presented to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 11, 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 28 of U.S. Patent No. 11246851 in view of www.pharmacorama.com (Routes of drug administration - Parenteral route) and Caffey et al. (U.S. Pat. Pub. 2011/0060280) as applied to claims 8-9 above, further in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the patented claim in view of www.pharmacorama.com and Caffey et al are addressed above. It would be prima facie obvious to optimize the concentration of furosemide within the taught range to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed value.
The patented claim in view of www.pharmacorama.com and Caffey et al does not expressly teach the isoosmolarity of the administered composition, but does teach the liquid composition for subcutaneous administration with a patch.
www.infusionnurse.org teaches that solutions to be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
Response to Arguments:
Applicant’s arguments are those presented to the patented claims which are addressed above.
Accordingly, the rejection stands.
Claims 1, 4-7, 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 43-45, 62-64 of copending Application No. 19/384267 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims recite the same method with the same components in ranges that fall within the instant claims wherein there is a case of obviousness. The amount of furosemide in the copending claims either fall within the claimed values or embrace them, and pH range amount of furosemide embraces the instant claimed range wherein it is prima facie obvious to optimize within the copending range and arrive at the claimed pH values and amount/concentration of furosemide with a reasonable expectation of success absent evidence of criticality for the claimed values.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments:
Applicant’s arguments center on the assertion that the copending claims are to about 50mg/ml-about 100mg/ml furosemide and about 25mM-about 100mM Tris and about 0.1-about 10% benzyl alcohol wherein the skilled artisan would not be motivated by the higher furosemide concentration and benzyl alcohol formulation in the patent to arrive at the instant claimed formulations that are for lower levels of furosemide.
This is fully considered but not persuasive. Contrary to Applicant’s assertion the instant claims recite the furosemide to be about 5mg/ml or greater wherein there is no upper limit for the amount of furosemide and the amount of furosemide in the copending claims fall within the instant claimed range. Also copending claims 62-64 are to furosemide that is about 10mg-200mg with a volume of about 0.5-about 10ml, wherein the concentration of furosemide is from about 1 mg/ml - 400mg/ml which embraces the instant claimed range wherein it would be prima facie obvious to optimize within the teachings and arrive at the claimed values as a means of attaining the desired therapeutic profile. The claims are also open language wherein it is open to the inclusion of other components.
Accordingly, the rejection stands.
Claim 2 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 43-45, 62-64 of copending Application No. 19/384267 (reference application) as applied to claims 1, 4-7, 25 above, in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the copending claims are addressed above.
The copending claims does not expressly teach the isoosmolarity of the administered composition, but does teach the liquid composition for administration.
www.infusionnurse.org teaches that solutions to be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments:
Applicant’s arguments are those presented to the copending claims which are addressed above.
Accordingly, the rejection stands.
Claims 8-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 43-45, 62-64 of copending Application No. 19/384267 (reference application) as applied to claims 1, 4-7, 25 above, in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of copending claims are addressed above.
The copending claims does not expressly teach the patch/pump means of subcutaneous administration but does teach subcutaneous administration including subcutaneous.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments:
Applicant’s arguments are those presented to the copending claims which are addressed above.
Accordingly, the rejection stands.
Claim 10 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 43-45, 62-64 of copending Application No. 19/384267 (reference application) as applied to claims 1, 4-7, 25 above, in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of copending claims are addressed above.
The copending claims does not expressly teach the intravenous administration of furosemide but does recite treating conditions like hypertension and edema with furosemide at from about 40mg/ml or more and subcutaneous administration.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of parenteral administration such as intravenous instead of subcutaneous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments:
Applicant’s arguments are those presented to the copending claims which are addressed above.
Accordingly, the rejection stands.
Claims 11, 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 43-45, 62-64 of copending Application No. 19/384267 (reference application) as applied to claims 8-9 above, in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of copending claims are addressed above including that the furosemide from about 10-about 200 in a volume of about 0.5-10ml wherein the amount/concentration of furosemide is about 1-400mg/ml wherein optimization within the range to arrive at the claimed concentration/amount is prima facie obvious absent evidence criticality for the claimed value.
The copending claims does not expressly teach the isoosmolarity of the administered composition, but does teach the liquid composition for administration such as subcutaneous.
www.infusionnurse.org teaches that solutions to be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments:
Applicant’s arguments are those presented to the copending claims which are addressed above.
Accordingly, the rejection stands.
Claims 1-2, 4-7, 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30-31 of copending Application No. 19/249224 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims recite the same method with the same components in ranges that fall within the instant claims wherein there is a case of obviousness or embrace the range (i.e. Tris amount in instant dependent claims) wherein it would be prima facie obvious to optimize the amount of Tris within the copending range and arrive at the instant claimed values as a means of attaining the desired therapeutic profile absent evidence of criticality for the claimed range. As the copending claims are isoosmotic it implicitly has osmotic agents/osmoregulators.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments:
Applicant asks for the rejection to be held in abeyance. There is no terminal disclaimer.
Accordingly, the rejection stands.
Claims 8-9, 11, 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30-31 of copending Application No. 19/249224 (reference application) as applied to claims 1-2, 4-7, 25 above, in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of copending claims are addressed above.
The copending claims does not expressly teach the patch/pump means of subcutaneous administration but does teach subcutaneous administration including subcutaneous.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 10 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over 30-31 of copending Application No. 19/249224 (reference application) as applied to claims 1-2, 4-7, 25 above, in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of copending claims are addressed above.
The copending claims does not expressly teach the intravenous administration of furosemide but does recite treating conditions like hypertension and edema with furosemide at 5 mg/ml or more and subcutaneous administration.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of parenteral administration such as intravenous instead of subcutaneous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-2, 4-11, 25-26 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613
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