DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/05/2026 has been entered.
Status of Application
The response filed 08/05/2026 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claims 1 and 8 have been amended.
Claims 7 and 10 has been cancelled.
Claims 1-2, 4-6, 8-9, 11, 25-26 are pending in the case.
Claims 1-2, 4-6, 8-9, 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All grounds not addressed in the action are withdrawn as a result of amendment.
Current Grounds of Rejection
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 1-2, 4-6, 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) and Beringer et al. (Parenteral Preparations -Overview of Unique Characteristics of Parenteral Dosage Forms, Added Substances, Route of Administration).
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 or tonicity/osmolarity of the parenteral composition or subcutaneous administration but does teach it for parenteral administration.
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.
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 formulate the pH and tonicity of the parenteral composition to be at physiological pH and isotonic levels, and administer it subcutaneously as suggested by The Pharmaceutics and Compounding Laboratory and Beringer et al. and produce the claimed invention; as Di Schiena teaches parenteral administration of furotris wherein it is prima facie obvious to optimize within the known ranges to attain an a isotonic and physiological pH which is desirable for parenteral forms with a reasonable expectation of success and a known form of parenteral administration such as subcutaneous with a reasonable expectation of success absent evidence of criticality for the claimed means.
Response to Arguments:
Applicant’s arguments are centered on the assertion that Di Schiena does not teach the claimed pH nor subcutaneous administration, that Di Schiena identifies a different pH range and that there is no reason to modify the pH, that pharmaceutical compositions for intravenous cannot necessarily be formulated for subcutaneous with a reasonable expectation of success as Di Schiena is to oral and intravenous and intramuscular administration, that while there are overlapping ranges the presumption of obviousness does not apply when the prior art encompasses variables that the Office must establish obviousness with motivation and reasonable expectation of success, the assertion for secondary considerations that the FDA approved drug marked under Furoscix covered by the instant claims has replaced traditional edema treatment methods for intravenous administration in a hospital setting, hindsight that Beringer does not disclose the claimed furosemide/Furotris/tris buffered furosemide formulation.
This is fully considered but not persuasive.
Applicant’s arguments to Di Schiena for pH and subcutaneous administration are these arguments are against the reference individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
As for the assertion that Di Schiena identified a different pH range and there’s no reason to modify the pH, this is not persuasive as Di Schiena merely addresses that the FuroTris compound in water is a pH of 6-6.5 (which is actually embraced by the instant range of about 7-about 8.5) where it is less affected by pH changes due to biological liquids, not that the formulation is a pH of 6-6.5 wherein it is desirable to have the parenteral formulation be the physiological pH as addressed by The Pharmaceutics and Compounding Laboratory to not vary significantly from that pH.
As for the assertion that pharmaceutical compositions for intravenous use cannot necessarily be formulated for subcutaneous with a reasonable expectation of success as Di Schiena is to oral and intravenous and intramuscular administration; this is not persuasive as contrary to Applicant’s assertion, Di Schiena is not limited to only intravenous and intramuscular administration as Di Schiena explicitly teaches it to be useful for parenteral administration which includes subcutaneous administration.
With regards to the assertion that a prima facie case of obviousness does not apply with the overlapping ranges when the prior art encompasses variables that the Office must establish obviousness with motivation and reasonable expectation of success is not persuasive as where claimed ranges “overlap of lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists (MPEP 2144.05 I). As for with motivation and reasonable expectation of success, this is not persuasive as it is prima facie obvious to optimize within known ranges as an isotonic and physiological pH is desirable to attain the desired profile with a reasonable expectation of success.
As for the assertion for secondary considerations, this is fully considered but not persuasive as there is no presentation for the exact content of Furoscix sold as referenced by Applicant and no evidence to document secondary considerations. Arguments without factual support are mere allegations and are not found persuasive.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to applicant's arguments against the Beringer reference individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Accordingly, the rejection stands.
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 1-2, 4-6, 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 of 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 centered on Caffery being a generic delivery device and that ither is not reason one would select a patch pump for the Furotris system of Di Schiena. This is fully considered but not persuasive. Applicant’s arguments to Di Schiena and subcutaneous use are addressed above. Caffery is presented merely to show known mean of subcutaneous drug delivery which include drug-delivery devices that have a skin patch and a pump 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 to utilize known forms subcutaneous drug delivery such as the one with a patch and pump for its known purpose with a reasonable expectation of success.
Accordingly, the rejection stands.
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, 4-6, 8-9, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-9 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. 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.
Claims 2, 11, 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-9 of U.S. Patent No. 12370168 as applied to claims 1, 4-6, 8-9, 11 above, in view of www.infusionnurse.org (Is there a difference? Osmolarity VS. Osmolality).
The patented claims 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.
Claims 1-2, 4-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12370168 in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The patented claims recites 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. furosemide amount in the independent claim, Tris amount in instant dependent claims) wherein it would be prima facie obvious to optimize the amount of furosemide and 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.
The patented claims does not expressly teach the subcutaneous administration of furosemide but does recite treating conditions like hypertension and edema with furosemide.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms of parenteral administration such as 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 asked for the rejection to be held in abeyance. There is no terminal disclaimer.
Accordingly, the rejection stands.
Claims 8-9, 11, 25-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12370168 in view of www.pharmacorama.com (Routes of drug administration - Parenteral route) as applied to claims 1-2, 4-6 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 is addressed above.
The patented claims in view of www.pharmacorama.com 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 of 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 asks for the rejection to be held in abeyance. There is no terminal disclaimer.
Accordingly, the rejection stands.
Claims 1-2, 4-6, 8-9, 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.
Claims 1-2, 4-6, 8-9, 11, 25-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-4, 6-23 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 overlaps in breath with instant claim 1 and claim 11 of about 30mg/ml (i.e. 25mg/ml) wherein even 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 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 in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The patented claims recite limitations that fall within the breath of the instant claims and the amount of furosemide in the patented claims overlap the claimed values (i.e. 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, and pH range (buffer/stabilizer) 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 claims does not expressly teach 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 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 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 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 5-about 30mg/ml wherein it overlaps the amount of furosemide (i.e. 35mg/ml) 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 in view of www.pharmacorama.com (Routes of drug administration - Parenteral route) 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 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 1, 4-6, 25 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 of 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 11, 26 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) 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 patented claim in view of www.pharmacorama.com and Caffery et al. are addressed above.
The patented claim in view of www.pharmacorama.com and Caffery et al. does not expressly teach the isoosmolarity of the administered composition, but does teach the liquid composition for parenteral administration including 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.
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 www.pharmacorama.com (Routes of drug administration - Parenteral route) and The Pharmaceutics and Compounding Laboratory (Guidelines, Equipment, and Supplies for Sterile Compounding –Physiological pH)..
The patented claims recite limitations that fall within the breath of the instant claims and the amount of furosemide in the patented claims overlap the claimed values (i.e. 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 claims does not expressly teach subcutaneous administration of furosemide or the pH range but does recite the method with the same furosemide and tromethamine for treating conditions like hypertension and edema with furosemide.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like subcutaneous.
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 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 subcutaneous and formulate the pH of the parenteral composition to be at physiological pH as suggested by www.pharmacorama.com and The Pharmaceutics and Compounding Laboratory wherein it is prima facie obvious to utilize the known desired physiological pH (7.4, buffer/stabilizer) and known modalities with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
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 5-about 30mg/ml wherein it overlaps the amount of furosemide (i.e. 35mg/ml) 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 www.pharmacorama.com (Routes of drug administration - Parenteral route) and 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 claims in view of The Pharmaceutics and Compounding Laboratory are addressed above.
The patented claim in view of www.pharmacorama.com and 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 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 www.pharmacorama.com (Routes of drug administration - Parenteral route) and The Pharmaceutics and Compounding Laboratory (Guidelines, Equipment, and Supplies for Sterile Compounding –Physiological pH) as applied to claims 1, 4-6 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 and The Pharmaceutics and Compounding Laboratory are addressed above.
The patented claim in view of www.pharmacorama.com and The Pharmaceutics and Compounding Laboratory 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 of 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 11, 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of U.S. Patent No. 12491195 in view of www.pharmacorama.com (Routes of drug administration - Parenteral route), The Pharmaceutics and Compounding Laboratory (Guidelines, Equipment, and Supplies for Sterile Compounding –Physiological pH) 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 patented claim in view of www.pharmacorama.com, The Pharmaceutics and Compounding Laboratory, and Caffery et al. are addressed above.
The patented claim in view of www.pharmacorama.com, The Pharmaceutics and Compounding Laboratory, and Caffery et al. 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 1, 4-6, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-13 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 for tris that fall within the breath of the instant claims and the amount of furosemide in the patented claims that overlap the claimed values (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; and pH range (buffer/stabilizer) 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.
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 5-about 30mg/ml wherein it overlaps the amount of furosemide (i.e. 35mg/ml) 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 12-13 of U.S. Patent No. 11998555 as applied to claims 1, 4-6 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 12-13 of U.S. Patent No. 11998555 as applied to claims 1, 4-6 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 of 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 11, 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-13 of U.S. Patent No. 11998555 in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280) as applied to claims 8-9 above, in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the patented claims in view of Caffery et al. are addressed above.
The patented claims in view of Caffery et al. 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 1, 4-6, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 11998555 in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The patented claims recite limitations for tris that fall within the breath of the instant claims and the amount of furosemide in the patented claims that overlap the claimed values (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; and pH range (buffer/stabilizer) 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 claims does not expressly teach the subcutaneous administration of furosemide but does recite treating conditions like hypertension and edema with furosemide.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like 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 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.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable claim 11 of U.S. Patent No. 11998555 in view of www.pharmacorama.com (Routes of drug administration - Parenteral route) as applied to claims 1, 4-6 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 are addressed above.
The patented claims in view of www.pharmacorama.com 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 claim 11 of U.S. Patent No. 11998555 in view of www.pharmacorama.com (Routes of drug administration - Parenteral route) as applied to claims 1, 4-6 above, further in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of patented claims in view of www.pharmacorama.comare addressed above.
The patented claims in view of www.pharmacorama.com 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 of 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 11, 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 11998555 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 Caffery et al. are addressed above.
The patented claims in view of www.pharmacorama.com and Caffery et al. 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 1, 4-6, 8, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-17 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 recited limitations that fall within the breath of the instant claims and the amount of furosemide overlaps the instant claims (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 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 5-about 30mg/ml wherein it overlaps the amount of furosemide (i.e. 35mg/ml) The arguments to Somberg is not persuasive as it is not part of the rejection. 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 15-17 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, 4-6, 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 with regards to The Pharmaceutics and Compounding Laboratory which are addressed above.
Accordingly, the rejection stands.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-17 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, 4-6, 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 of 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 and The Pharmaceutics and Compounding Laboratory which are addressed above.
Accordingly, the rejection stands.
Claims 1, 4-6, 8, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 12491193 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).
The patented claim recited limitations that fall within the breath of the instant claims and the amount of furosemide overlaps the instant claims (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 or subcutaneous administration 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.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
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 and utilize subcutaneous administration as suggested by The Pharmaceutics and Compounding Laboratory and www.pharmacorama.com and produce the claimed invention; as it is prima facie obvious to utilize the known desired physiological pH (7.4) and known forms of parenteral administration with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
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 5-about 30mg/ml wherein it overlaps the amount of furosemide (i.e. 35mg/ml). The arguments to Somberg is not persuasive as it is not part of the rejection. 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 15-17 of U.S. Patent No. 12491193 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 1, 4-6, 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 and www.pharmacorama.com 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 15-17 of U.S. Patent No. 12491193 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 1, 4-6, 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 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 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 of 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 1, 4-6, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 12491194.
Although the claim at issue are not identical, it is not patentably distinct from each other because the patented claim recite limitations that fall within the breath of the instant claims and the amount of furosemide in the patented claim overlaps the instant claims (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, and pH range and amount of tromethamine 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 tromethamine 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 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 5-about 30mg/ml wherein it overlaps the amount of furosemide (i.e. 35mg/ml). 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 6 of U.S. Patent No. 12491194 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 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 12491194 as applied to claims 1, 4-6, 25 above, in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of patented claim are addressed above.
The patented claim 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 of 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 6 of U.S. Patent No. 12491194 in view of 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 Caffery et al. are addressed above.
The patented claim in view of Caffery et al. 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 1, 4-6, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 12491194 in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The patented claim recite limitations that fall within the breath of the instant claims and the amount of furosemide in the patented claim overlaps the instant claims (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, and pH range and amount of tromethamine 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 tromethamine with a reasonable expectation of success absent evidence of criticality for the claimed values.
The patented claims does not expressly teach the subcutaneous administration of furosemide but does recite treating conditions like hypertension and edema with furosemide.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms of parenteral administration such as 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.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 12491194 in view of www.pharmacorama.com (Routes of drug administration - Parenteral route) as applied to claims 1, 4-6, 25 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 are addressed above.
The patented claim in view of www.pharmacorama.com 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 claim 5 of U.S. Patent No. 12491194 in view of www.pharmacorama.com (Routes of drug administration - Parenteral route) as applied to claims 1, 4-6, 25 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 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 of 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 6 of U.S. Patent No. 12491194 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 Caffery et al. are addressed above.
The patented claim in view of www.pharmacorama.com and Caffery et al. 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 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 in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
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 (buffer/stabilizer) 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.
The patented claims does not expressly teach 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 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 5-about 30mg/ml 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 and the instant claims do not require a molar ratio.
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 in view of www.pharmacorama.com (Routes of drug administration - Parenteral route) as applied to claims 1, 4-6, 25 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 are addressed above.
The patented claims in view of www.pharmacorama.com 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 23-26 of U.S. Patent No. 12403120 in view of www.pharmacorama.com (Routes of drug administration - Parenteral route) as applied to claims 1, 4-6, 25 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.
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 of 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 in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The patented claims recite limitations 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.
The patented claim does not expressly teach 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 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 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 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 5-about 30 mg/ml 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 in view of www.pharmacorama.com (Routes of drug administration - Parenteral route) as applied to claims 1, 4-6, 25 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 are addressed above.
The patented claim in view of www.pharmacorama.com 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 claim 28 of U.S. Patent No. 11246851 in view of www.pharmacorama.com (Routes of drug administration - Parenteral route) as applied to claims 1, 4-6, 25 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 of 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, 4-6, 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 63-64 of copending Application No. 19/384267 (reference application).
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 overlap the instant claimed range 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 even a slight overlap in ranges for furosemide establishes a prima facie case of obviousness 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 5-about 30mg/ml and the amount of furosemide in the copending claims 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 63-64 of copending Application No. 19/384267 (reference application) 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 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 63-64 of copending Application No. 19/384267 (reference application) as applied to claims 1, 4-6, 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 of 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.
Claims 11, 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 63-64 of copending Application No. 19/384267 (reference application) in view of 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 copending claims in view of Caffery et al. 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 in view of Caffery et al. 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, 4-6, 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 62 of copending Application No. 19/384267 (reference application) in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
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 overlap the instant claimed range 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 even a slight overlap in ranges for furosemide establishes a prima facie case of obviousness with a reasonable expectation of success absent evidence of criticality for the claimed values.
The copending claims does not expressly teach the subcutaneous administration of furosemide but does recite treating conditions like hypertension and edema with furosemide.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like 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 center on the assertion that the copending claim is 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 5-about 30mg/ml and the amount of furosemide in the copending claim is 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 claim 62 of copending Application No. 19/384267 (reference application) in view of www.pharmacorama.com (Routes of drug administration - Parenteral route) as applied to claims 1, 4-6, 25 above, further in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the copending claims in view of www.pharmacorama.com are addressed above.
The copending claims in view of www.pharmacorama.com 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 claim 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 claim 62 of copending Application No. 19/384267 (reference application) in view of www.pharmacorama.com (Routes of drug administration - Parenteral route) as applied to claims 1, 4-6, 25 above, further in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of copending claims in view of www.pharmacorama.com are addressed above.
The copending claims in view of www.pharmacorama.com 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 of 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.
Claims 11, 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 62 of copending Application No. 19/384267 (reference application) in view of 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 copending claim in view of Caffery et al. 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 claim in view of Caffery et al. 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, 4-6, 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 31 of copending Application No. 19/249224 (reference application).
Although the claim at issue are not identical, it is not patentably distinct from each other because the copending claim 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. furosemide amount in the independent claim, Tris amount in instant dependent claims) wherein it would be prima facie obvious to optimize the amount of furosemide and 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 claim 31 of copending Application No. 19/249224 (reference application) as applied to claims 1-2, 4-6, 25 above, in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of copending claim is addressed above.
The copending claim 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 of 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 asks for the rejection to be held in abeyance. There is no terminal disclaimer.
Accordingly, the rejection stands.
Claims 1-2, 4-6, 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 30 of copending Application No. 19/249224 (reference application) in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The copending claim recites 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. furosemide amount in the independent claim, Tris amount in instant dependent claims) wherein it would be prima facie obvious to optimize the amount of furosemide and 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.
The copending claim does not expressly teach the subcutaneous administration of furosemide but does recite treating conditions like hypertension and edema with furosemide.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms of parenteral administration such as 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 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 claim 30 of copending Application No. 19/249224 (reference application) in view of www.pharmacorama.com (Routes of drug administration - Parenteral route) as applied to claims 1-2, 4-6, 25 above, in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of copending claim in view of www.pharmacorama.com is addressed above.
The copending claim in view of www.pharmacorama.com 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 of 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 asks for the rejection to be held in abeyance. There is no terminal disclaimer.
Accordingly, the rejection stands.
Conclusion
Claims 1-2, 4-6, 8-9, 11, 25-26 are rejected.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613
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