DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 01/28/2026 is acknowledged. Applicant did not fully respond to the election of species requirement. A call was placed Applicant and a message left to obtain the election of species. A message from Applicant was received stating that the election of species of the disease condition would be edema and the election of species for the mode of administration was subcutaneous. Upon review the election of species for the disease condition and mode of administration are withdrawn.
Status of Application
Applicant has elected Group I in response to restriction requirement and elected the species of disease condition to be edema and the election of species for the mode of administration to be subcutaneous for the examination.
Upon review the election of species for the disease condition and mode of administration are withdrawn.
Claims 1-2, 4-11, 25-26 are pending.
Claims 1-2, 4-11, 25-26 are present for examination at this time.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 6 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claim recites the amount of furosemide to be “about 30mg” in the composition wherein the specification does not support for the liquid composition to be administered for the claimed method to contain “about 30mg” of furosemide. The specification does support for the claimed method to have furosemide to be present at a concentration of “about 30mg/mL” in the liquid composition but not at the amount of “about 30mg”.
This is a new matter rejection.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claim is unclear as it is cited to be previously presented but the claim as previously presented was to furosemide to be “about 30mg/mL” but is currently presented to be “about 30mg” which is different from “about 30mg/mL” and there is no indication of claim amendment wherein it is unclear if the claim is meant to be “about 30mg” as currently indicated despite the lack of amendment or the claim status of “previously presented”, or meant to be “about 30mg/mL” as previously presented as indicated by the claim identifier. It does not allow one to ascertain the metes and bounds of the claim as written. For purposes of examination it is treated as be “about 30mg” wherein the issue of new matter is addressed above.
Claims 25-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claims recite the inclusion of “one or more pharmaceutical additives selected from solubilizers, emulsifiers, buffers, preservatives, sweeteners, flavoring agents, suspending agents, thickening agents, colors, viscosity regulators, stabilizers, and osmo-regulators” but the independent claims recite the presence of a tris buffer wherein it is unclear if the claims are to the same tris buffer or to additional buffers. It does not allow one to ascertain the metes and bounds of the claimed invention. For purposes of examination, the claims are treated to include the tris buffer.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4-5, 10, 25 are rejected under 35 U.S.C. 103 as being unpatentable over Ranade (U.S. Pat. 5814623) in view of Somberg et al. (U.S. Pat. Pub. 2012/0077829).
Rejection:
Ranade teaches a method of treating hypertension and edema and heart failure with the parenteral administration of a composition comprising furosemide and metolazone and a buffer comprising tris(hydroxymethyl)aminomethane (abstract, Table V, claims 9 and 11-12, col. 2 line 22-35). The concentration of tris(hydroxymethyl)aminomethane (Tris buffer solution) is in the specific range of about 0.05M (50mM) to about 0.5M (500mM), and typically 0.05M (50mM). Table V teaches the solution with 0.5ml of furosemide at the concentration of 4mg/ml, with metolazone and the Tris buffer solution (0.05M =50mM, see full document specifically areas cited).
Ranade does not expressly teach the recited pH for the administered composition.
Somberg et al. teaches that pharmaceutical parenteral compositions comprising metolazone and furosemide to be at a pH of 6.8-8 as previous formulations were alkaline solutions with pH greater than 9 - where the alkaline pH degraded the active and it is not desirable to admix highly alkaline solutions with bodily fluids in vivo.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to modify the pH to the pH range of 6.8-8 and optimize within the range, as Somberg teaches that having a pH greater than 9 degraded the active and it is not desirable to admix highly alkaline solutions with bodily fluids in vivo, with a reasonable expectation of success.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Ranade (U.S. Pat. 5814623) in view of Somberg et al. (U.S. Pat. Pub. 2012/0077829) as applied to claims 1, 4-5, 10, 25 above, further in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
Rejection:
The teachings of Ranade in view of Somberg et al. are addressed above.
Ranade in view of Somberg et al. does not expressly teach the isoosmolarity of the administered composition, but does teach the composition to be for parenteral/infusion administration.
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Ranade (U.S. Pat. 5814623) in view of Somberg et al. (U.S. Pat. Pub. 2012/0077829) as applied to claims 1, 4-5, 10, 25 above, further in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
Rejection:
The teachings of Ranade in view of Somberg et al. are addressed above.
Ranade in view of Somberg et al. does not expressly teach subcutaneous administration but does expressly teach parenteral administration such as intravenous administration.
www.pharmacorama.com teaches that known parenteral administration forms include subcutaneous and intravenous.
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 administration as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Ranade (U.S. Pat. 5814623) in view of Somberg et al. (U.S. Pat. Pub. 2012/0077829) and www.pharmacorama.com (Routes of drug administration - Parenteral route) as applied to claim 7 above, further in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
Rejection:
The teachings of Ranade in view of Somberg et al. and www.pharmacorama.com are addressed above.
Ranade in view of Somberg et al. and www.pharmacorama.com does not expressly teach the patch/pump means of subcutaneous administration but does teach parenteral administration including subcutaneous.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Ranade (U.S. Pat. 5814623) in view of Somberg et al. (U.S. Pat. Pub. 2012/0077829) as applied to claims 1, 4-5, 10, 25 above, further in view of MacLaughlan (WO 96/24372).
Rejection:
The teachings of Ranade in view of Somberg et al. are addressed above.
Ranade in view of Somberg et al. does not expressly teach the recited amount of furosemide but does teach treating conditions including hypertension with furosemide in combination with metolazone and a tris buffer, with exemplification of furosemide at 4mg/ml with 0.5ml administered (2mg).
MacLaughlan teaches that furosemide (diuretic) is known to be useful for hypertension and heart failure and in combination therapy by intravenous and subcutaneous injection (abstract, Page 1 line 9-19, Page 19 line 1-5, Page 32 line17-19), where the diuretic like furosemide can be from about 1mg-about 200mg (Page 33 line 15-19).
Wherein it would be obvious before the effective filing date of the claimed invention to incorporate the furosemide at the recited amount as suggested by MacLaughlan and produce the claimed invention; as it is prima facie obvious to incorporate the furosemide in the composition at its known dosage range and optimize the amount to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed value.
Claims 11, 26 are rejected under 35 U.S.C. 103 as being unpatentable over Ranade (U.S. Pat. 5814623) in view of Somberg et al. (U.S. Pat. Pub. 2012/0077829) and 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) and MacLaughlan (WO 96/24372).
Rejection:
The teachings of Ranade in view of Somberg et al. and www.pharmacorama.com and Caffey et al. are addressed above.
Ranade in view of Somberg et al. and www.pharmacorama.com and Caffey et al. does not expressly teach the isoosmolarity of the administered composition or the recited amount of furosemide; but does teach the parenteral/infusion composition to be for treating conditions including hypertension with furosemide in combination with metolazone and a tris buffer with exemplification of furosemide at 4mg/ml with 0.5ml administered (2mg).
www.infusionnurse.org teaches that infused solutions be isosmotic/isotonic (e.g. with 0.9% sodium chloride (osmotic agent/osmo-regulator)), 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.
MacLaughlan teaches that furosemide (diuretic) is known to be useful for hypertension and heart failure and in combination therapy by intravenous and subcutaneous injection (abstract, Page 1 line 9-19, Page 19 line 1-5, Page 32 line17-19), where the diuretic like furosemide can be from about 1mg-about 200mg (Page 33 line 15-19).
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic and incorporate the furosemide at the recited amount/concentration as suggested by www.infusionnurse.org and MacLaughlan and produce the claimed invention; as by being isosmotic with osmotic agents- 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. It would also be prima facie obvious to incorporate the furosemide in the composition at its known dosage range (i.e. about 1mg-about 200mg) such as the exemplified volume (i.e. 0.5ml, 4mg/ml at 0.5ml=2mg, 30mg/ml at 0.5ml=60mg) and optimize the amount to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed value.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4-5, 7-9, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12370168.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims fall within the breath of the instant claims wherein a case of obviousness is present.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12370168 as applied to claims 1-2, 4-5, 7-10, 25 above, in view of MacLaughlan (WO 96/24372).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the recited amount of furosemide but does recite treating conditions like hypertension with furosemide at 5mg/ml or more.
MacLaughlan teaches that furosemide (diuretic) is known to be useful for hypertension and heart failure by intravenous and subcutaneous injection (abstract, Page 1 line 9-19, Page 19 line 1-5, Page 32 line17-19), where the diuretic like furosemide can be from about 1mg-about 200mg (Page 33 line 15-19).
Wherein it would be obvious before the effective filing date of the claimed invention to incorporate the furosemide at the recited amount as suggested by MacLaughlan and produce the claimed invention; as it is prima facie obvious to incorporate the furosemide in the composition at its known dosage range and optimize the amount to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed value.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12370168 as applied to claims 1-2, 4-5, 7-9, 25 above, in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the intravenous administration of furosemide but does recite treating conditions like hypertension with furosemide at 5mg/ml or more.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of administration such as parenteral administration like intravenous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
Claims 11, 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 12370168 in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The patented claim recites the same instant claimed method with the same components in ranges falling within the instant claimed values.
www.infusionnurse.org teaches that infused solutions be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
Claims 1-2, 4-5, 7-9, 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 recite limitations that fall within the breath of the instant claims and the concentration of furosemide in the patented claims either fall within the claimed values wherein it is obvious, or the amount of furosemide embraces those of the instant claim 11 wherein optimization of the patented range to arrive at the instant values is prima facie obvious with a reasonable expectation of success absent evidence of criticality for the claimed value.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11433044 as applied to claims 1-2, 4-5, 7-11, 25-26 above, in view of MacLaughlan (WO 96/24372).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the recited amount of furosemide but does recite treating conditions like hypertension with furosemide at various concentrations.
MacLaughlan teaches that furosemide (diuretic) is known to be useful for hypertension and heart failure by intravenous and subcutaneous injection (abstract, Page 1 line 9-19, Page 19 line 1-5, Page 32 line17-19), where the diuretic like furosemide can be from about 1mg-about 200mg (Page 33 line 15-19).
Wherein it would be obvious before the effective filing date of the claimed invention to incorporate the furosemide at the recited amount as suggested by MacLaughlan and produce the claimed invention; as it is prima facie obvious to incorporate the furosemide in the composition at its known dosage range and optimize the amount to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed value.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11433044 as applied to claims 1-2, 4-5, 7-11, 25-26 above, in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the intravenous administration of furosemide but does recite treating conditions like hypertension with furosemide administered subcutaneously.
www.pharmacorama.com teaches that known means of parenteral administration include intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of parenteral administration like intravenous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
Claims 1-2, 4-5, 7-10, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 9884039.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite limitations that fall within the breath of the instant claims and the amount of furosemide in the patented claims either fall within the claimed values wherein it is obvious, or the amount of furosemide overlaps those of the instant claims (e.g. 25mg/ml is an overlapping value as it is embraced by the patented range and the instant claimed range) wherein even a slight overlap in ranges establishes a prima facie case of obviousness.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 9884039 as applied to claims 1-2, 4-5, 7-10, 25 above, in view of MacLaughlan (WO 96/24372).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the recited amount of furosemide but does recite treating conditions like hypertension with furosemide at various concentrations.
MacLaughlan teaches that furosemide (diuretic) is known to be useful for hypertension and heart failure by intravenous and subcutaneous injection (abstract, Page 1 line 9-19, Page 19 line 1-5, Page 32 line17-19), where the diuretic like furosemide can be from about 1mg-about 200mg (Page 33 line 15-19).
Wherein it would be obvious before the effective filing date of the claimed invention to incorporate the furosemide at the recited amount as suggested by MacLaughlan and produce the claimed invention; as it is prima facie obvious to incorporate the furosemide in the composition at its known dosage range and optimize the amount to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed value.
Claims 11, 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-23 of U.S. Patent No. 9884039 in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The patented claims recite the same method with the same components of the instant claims and the amount of furosemide in the patented claims overlaps those of the instant claims (e.g. 25mg/ml is an overlapping value as it is embraced by the patented range and the instant claimed range) wherein even a slight overlap in ranges establishes a prima facie case of obviousness. The patented claims recite subcutaneous administration and pump device.
The patented claims do not recite a patch for subcutaneous administration but does recite subcutaneous administration and pump device.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
Claims 1, 4-5, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of U.S. Patent No. 12491195.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite limitations that fall within the breath of the instant claims and the amount of furosemide in the patented claims that fall within the claimed values and pH range that embraces the instant claimed range wherein it is prima facie obvious to optimize within the patented range and arrive at the claimed pH values with a reasonable expectation of success absent evidence of criticality for the claimed values.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of U.S. Patent No. 12491195 as applied to claims 1, 4-5, 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.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of U.S. Patent No. 12491195 as applied to claims 1, 4-5, 25 above, in view of MacLaughlan (WO 96/24372).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the recited amount of furosemide but does recite treating conditions like hypertension with furosemide at various concentrations.
MacLaughlan teaches that furosemide (diuretic) is known to be useful for hypertension and heart failure by intravenous and subcutaneous injection (abstract, Page 1 line 9-19, Page 19 line 1-5, Page 32 line17-19), where the diuretic like furosemide can be from about 1mg-about 200mg (Page 33 line 15-19).
Wherein it would be obvious before the effective filing date of the claimed invention to incorporate the furosemide at the recited amount as suggested by MacLaughlan and produce the claimed invention; as it is prima facie obvious to incorporate the furosemide in the composition at its known dosage range and optimize the amount to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed value.
Claims 7, 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of U.S. Patent No. 12491195 as applied to claims 1, 4-5, 25 above, in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of patented claim are addressed above.
The patented claims does not expressly teach the intravenous or subcutaneous administration of furosemide but does recite treating conditions like hypertension and edema with furosemide at 5mg/ml or more.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of administration such as parenteral administration like intravenous and subcutaneous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of U.S. Patent No. 12491195 in view of www.pharmacorama.com (Routes of drug administration - Parenteral route) as applied to claims 7, 10 above, further in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of patented claim in view of www.pharmacorama.com are addressed above.
The patented claim in view of www.pharmacorama.com does not expressly teach the patch/pump means of subcutaneous administration but does teach parenteral administration including subcutaneous.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
Claims 1, 4-5, 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 Somberg et al. (U.S. Pat. Pub. 2012/0077829).
The patented claim recite limitations that fall within the breath of the instant claims and the amount of furosemide in the patented claims that fall within the claimed values.
The patented claim does not recite the pH range but does teach the method with the same furosemide and tromethamine.
Somberg et al. teaches that pharmaceutical parenteral compositions comprising metolazone and furosemide to be at a pH of 6.8-8 as previous formulations were alkaline solutions with pH greater than 9 - where the alkaline pH degraded the active and it is not desirable to admix highly alkaline solutions with bodily fluids in vivo.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to modify the pH to the pH range of 6.8-8 and optimize within the range, as Somberg teaches that having a pH greater than 9 degraded the active and it is not desirable to admix highly alkaline solutions with bodily fluids in vivo, with a reasonable expectation of success.
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 Somberg et al. (U.S. Pat. Pub. 2012/0077829) as applied to claims 1, 4-5, 25, further in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the patented claim in view of Somberg et al. are addressed above.
The patented claim in view of Somberg 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.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of U.S. Patent No. 12491195 in view of Somberg et al. (U.S. Pat. Pub. 2012/0077829) as applied to claims 1, 4-5, 25 above, in view of MacLaughlan (WO 96/24372).
The teachings of patented claims in view of Somberg et al. are addressed above.
The patented claims in view of Somberg et al. does not expressly teach the recited amount of furosemide but does recite treating conditions like hypertension with furosemide at various concentrations.
MacLaughlan teaches that furosemide (diuretic) is known to be useful for hypertension and heart failure by intravenous and subcutaneous injection (abstract, Page 1 line 9-19, Page 19 line 1-5, Page 32 line17-19), where the diuretic like furosemide can be from about 1mg-about 200mg (Page 33 line 15-19).
Wherein it would be obvious before the effective filing date of the claimed invention to incorporate the furosemide at the recited amount as suggested by MacLaughlan and produce the claimed invention; as it is prima facie obvious to incorporate the furosemide in the composition at its known dosage range and optimize the amount to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed value.
Claims 7, 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of U.S. Patent No. 12491195 in view of Somberg et al. (U.S. Pat. Pub. 2012/0077829) as applied to claims 1, 4-5, 25 above, further in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of patented claim in view of Somberg et al. are addressed above.
The patented claim in view of Somberg et al. does not expressly teach the intravenous or subcutaneous administration of furosemide but does recite treating conditions like hypertension and edema with furosemide at 5mg/ml or more.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of administration such as parenteral administration like intravenous and subcutaneous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
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 Somberg et al. (U.S. Pat. Pub. 2012/0077829) and www.pharmacorama.com (Routes of drug administration - Parenteral route) as applied to claims 7, 10 above, further in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of patented claim in view of Somberg et al. and www.pharmacorama.com are addressed above.
The patented claim in view of Somberg et al. and www.pharmacorama.com does not expressly teach the patch/pump means of subcutaneous administration but does teach parenteral administration including subcutaneous.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
Claims 1, 4-5, 7, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-13 of U.S. Patent No. 11998555.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite limitations that fall within the breath of the instant claims and the amount of furosemide in the patented claims that fall within the claimed values and pH range that embraces the instant claimed range wherein it is prima facie obvious to optimize within the patented range and arrive at the claimed pH values with a reasonable expectation of success absent evidence of criticality for the claimed values.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-13 of U.S. Patent No. 11998555 as applied to claims 1, 4-5, 7, 25 above, in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the patented claims are addressed above.
The patented claims does not expressly teach the isoosmolarity of the administered composition, but does teach the liquid composition for administration.
www.infusionnurse.org teaches that solutions to be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-13 of U.S. Patent No. 11998555 as applied to claims 1, 4-5, 7, 25 above, in view of MacLaughlan (WO 96/24372).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the recited amount of furosemide but does recite treating conditions like hypertension with furosemide at various concentrations.
MacLaughlan teaches that furosemide (diuretic) is known to be useful for hypertension and heart failure by intravenous and subcutaneous injection (abstract, Page 1 line 9-19, Page 19 line 1-5, Page 32 line17-19), where the diuretic like furosemide can be from about 1mg-about 200mg (Page 33 line 15-19).
Wherein it would be obvious before the effective filing date of the claimed invention to incorporate the furosemide at the recited amount as suggested by MacLaughlan and produce the claimed invention; as it is prima facie obvious to incorporate the furosemide in the composition at its known dosage range and optimize the amount to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed value.
Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-13 of U.S. Patent No. 11998555 as applied to claims 1, 4-5, 7, 25 above, in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the patch/pump means of subcutaneous administration but does teach subcutaneous administration including subcutaneous.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-13 of U.S. Patent No. 11998555 as applied to claims 1, 4-5, 7, 25 above, in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the intravenous administration of furosemide but does recite treating conditions like hypertension and edema with furosemide at from about 40mg/ml or more and subcutaneous administration.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of parenteral administration such as intravenous instead of subcutaneous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
Claims 1, 4-7, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-8 of U.S. Patent No. 12042709.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite limitations that fall within the breath of the instant claims and the amount of furosemide in the patented claims that fall within the claimed values and pH range amount of furosemide embraces the instant claimed range wherein it is prima facie obvious to optimize within the patented range and arrive at the claimed pH values and amount of furosemide with a reasonable expectation of success absent evidence of criticality for the claimed values.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-8 of U.S. Patent No. 12042709 as applied to claims 1, 4-7, 25 above, in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the patented claims are addressed above.
The patented claims does not expressly teach the isoosmolarity of the administered composition, but does teach the liquid composition for administration.
www.infusionnurse.org teaches that solutions to be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-8 of U.S. Patent No. 12042709 as applied to claims 1, 4-7, 25 above, in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the patch/pump means of subcutaneous administration but does teach subcutaneous administration including subcutaneous.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-8 of U.S. Patent No. 12042709 as applied to claims 1, 4-7, 25 above, in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the intravenous administration of furosemide but does recite treating conditions like hypertension and edema with furosemide at from about 40mg/ml or more and subcutaneous administration.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of parenteral administration such as intravenous instead of subcutaneous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
Claims 1, 4-5, 7-8, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-17 of U.S. Patent No. 12491193 in view of Somberg et al. (U.S. Pat. Pub. 2012/0077829).
The patented claim recite limitations that fall within the breath of the instant claims and the amount of furosemide in the patented claims that fall within the claimed values.
The patented claim does not recite the pH range but does teach the method with the same furosemide and tromethamine.
Somberg et al. teaches that pharmaceutical parenteral compositions comprising metolazone and furosemide to be at a pH of 6.8-8 as previous formulations were alkaline solutions with pH greater than 9 - where the alkaline pH degraded the active and it is not desirable to admix highly alkaline solutions with bodily fluids in vivo.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to modify the pH to the pH range of 6.8-8 and optimize within the range, as Somberg teaches that having a pH greater than 9 degraded the active and it is not desirable to admix highly alkaline solutions with bodily fluids in vivo, with a reasonable expectation of success.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-17 of U.S. Patent No. 12491193 in view of Somberg et al. (U.S. Pat. Pub. 2012/0077829) as applied to claims 1, 4-5, 7-8, 25, further in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the patented claim in view of Somberg et al. are addressed above.
The patented claim in view of Somberg 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.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-17 of U.S. Patent No. 12491193 in view of Somberg et al. (U.S. Pat. Pub. 2012/0077829) as applied to claims 1, 4-5, 7-8, 25 above, in view of MacLaughlan (WO 96/24372).
The teachings of patented claims in view of Somberg et al. are addressed above.
The patented claims in view of Somberg et al. does not expressly teach the recited amount of furosemide but does recite treating conditions like hypertension with furosemide at various concentrations.
MacLaughlan teaches that furosemide (diuretic) is known to be useful for hypertension and heart failure by intravenous and subcutaneous injection (abstract, Page 1 line 9-19, Page 19 line 1-5, Page 32 line17-19), where the diuretic like furosemide can be from about 1mg-about 200mg (Page 33 line 15-19).
Wherein it would be obvious before the effective filing date of the claimed invention to incorporate the furosemide at the recited amount as suggested by MacLaughlan and produce the claimed invention; as it is prima facie obvious to incorporate the furosemide in the composition at its known dosage range and optimize the amount to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed value.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-17 of U.S. Patent No. 12491193 in view of Somberg et al. (U.S. Pat. Pub. 2012/0077829) as applied to claims 1, 4-5, 7-8, 25 above, further in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of patented claim in view of Somberg et al. are addressed above.
The patented claim in view of Somberg et al. does not expressly teach the patch/pump means of subcutaneous administration but does teach subcutaneous administration.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over 14-17 of U.S. Patent No. 12491193 in view of Somberg et al. (U.S. Pat. Pub. 2012/0077829) as applied to claims 1, 4-5, 7-8, 25 above, further in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of patented claim in view of Somberg et al. are addressed above.
The patented claim in view of Somberg et al. does not expressly teach the intravenous administration of furosemide but does recite treating conditions like hypertension and edema with furosemide such as with subcutaneous administration.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of parenteral administration like intravenous rather than subcutaneous with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
Claims 1, 4-7, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-6 of U.S. Patent No. 12491194.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite limitations that fall within the breath of the instant claims and the amount of furosemide in the patented claims that fall within the claimed values and pH range amount of furosemide embraces the instant claimed range wherein it is prima facie obvious to optimize within the patented range and arrive at the claimed pH values and amount of furosemide with a reasonable expectation of success absent evidence of criticality for the claimed values.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-6 of U.S. Patent No. 12491194 as applied to claims 1, 4-7, 25 above, in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the patented claims are addressed above.
The patented claims does not expressly teach the isoosmolarity of the administered composition, but does teach the liquid composition for administration.
www.infusionnurse.org teaches that solutions to be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-6 of U.S. Patent No. 12491194 as applied to claims 1, 4-7, 25 above, in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the patch/pump means of subcutaneous administration but does teach subcutaneous administration including subcutaneous.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-6 of U.S. Patent No. 12491194 as applied to claims 1, 4-7, 25 above, in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the intravenous administration of furosemide but does recite treating conditions like hypertension and edema with furosemide at from about 40mg/ml or more and subcutaneous administration.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of parenteral administration such as intravenous instead of subcutaneous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
Claims 1, 4-7, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-5 of U.S. Patent No. 12491196.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite limitations that fall within the breath of the instant claims and the amount of furosemide in the patented claims that fall within the claimed values and pH range amount of furosemide embraces the instant claimed range wherein it is prima facie obvious to optimize within the patented range and arrive at the claimed pH values and amount of furosemide with a reasonable expectation of success absent evidence of criticality for the claimed values.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-5 of U.S. Patent No. 12491196 as applied to claims 1, 4-7, 25 above, in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the patented claims are addressed above.
The patented claims does not expressly teach the isoosmolarity of the administered composition, but does teach the liquid composition for administration.
www.infusionnurse.org teaches that solutions to be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-5 of U.S. Patent No. 12491196 as applied to claims 1, 4-7, 25 above, in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the patch/pump means of subcutaneous administration but does teach subcutaneous administration including subcutaneous.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-5 of U.S. Patent No. 12491196 as applied to claims 1, 4-7, 25 above, in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the intravenous administration of furosemide but does recite treating conditions like hypertension and edema with furosemide at from about 40mg/ml or more and subcutaneous administration.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of parenteral administration such as intravenous instead of subcutaneous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
Claims 1, 4-5, 7, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-21 of U.S. Patent No. 12491196.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite limitations that fall within the breath of the instant claims and the amount of furosemide in the patented claims that fall within the claimed values and pH range amount of furosemide embraces the instant claimed range wherein it is prima facie obvious to optimize within the patented range and arrive at the claimed pH values and amount of furosemide with a reasonable expectation of success absent evidence of criticality for the claimed values.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-21 of U.S. Patent No. 12491196 as applied to claims 1, 4-5, 7, 25 above, in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the patented claims are addressed above.
The patented claims does not expressly teach the isoosmolarity of the administered composition, but does teach the liquid composition for administration.
www.infusionnurse.org teaches that solutions to be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-21 of U.S. Patent No. 12491196 as applied to claims 1, 4-5, 7, 25 above, in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the patch/pump means of subcutaneous administration but does teach subcutaneous administration including subcutaneous.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-21 of U.S. Patent No. 12491196 as applied to claims 1, 4-5, 7, 25 above, in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the intravenous administration of furosemide but does recite treating conditions like hypertension and edema with furosemide at from about 40mg/ml or more and subcutaneous administration.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of parenteral administration such as intravenous instead of subcutaneous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
Claims 1, 4-5, 7, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-7, 19-20 of U.S. Patent No. 12491197.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite limitations that fall within the breath of the instant claims and the amount of furosemide in the patented claims that fall within the claimed values and pH range amount of furosemide embraces the instant claimed range wherein it is prima facie obvious to optimize within the patented range and arrive at the claimed pH values and amount of furosemide with a reasonable expectation of success absent evidence of criticality for the claimed values.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-7, 19-20 of U.S. Patent No. 12491197 as applied to claims 1, 4-5, 7, 25 above, in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the patented claims are addressed above.
The patented claims does not expressly teach the isoosmolarity of the administered composition, but does teach the liquid composition for administration.
www.infusionnurse.org teaches that solutions to be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-7, 19-20 of U.S. Patent No. 12491197 as applied to claims 1, 4-5, 7, 25 above, in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the patch/pump means of subcutaneous administration but does teach subcutaneous administration including subcutaneous.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-7, 19-20 of U.S. Patent No. 12491197as applied to claims 1, 4-5, 7, 25 above, in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the intravenous administration of furosemide but does recite treating conditions like hypertension and edema with furosemide at from about 40mg/ml or more and subcutaneous administration.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of parenteral administration such as intravenous instead of subcutaneous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
Claims 1, 4-5, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-26 of U.S. Patent No. 12403120.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite limitations that fall within the breath of the instant claims and the amount of furosemide in the patented claims that fall within the claimed values (about 10mg/ml-about 30mg/ml, about 60mM-about 95mM=about 19.8mg/ml-about 31mg/ml) and the pH and tris range either fall within the instant ranges or overlaps them wherein even a slight overlap in ranges establishes a prima facie case of obviousness with a reasonable expectation of success absent evidence of criticality for the claimed values.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-26 of U.S. Patent No. 12403120 as applied to claims 1, 4-5, 25 above, in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the patented claims are addressed above.
The patented claims does not expressly teach the isoosmolarity of the administered composition, but does teach the liquid composition for administration.
www.infusionnurse.org teaches that solutions to be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-26 of U.S. Patent No. 12403120 as applied to claims 1, 4-5, 25 above, in view of MacLaughlan (WO 96/24372).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the recited amount of furosemide but does recite treating conditions like heart failure and hypertension with furosemide at various concentrations.
MacLaughlan teaches that furosemide (diuretic) is known to be useful for hypertension and heart failure by intravenous and subcutaneous injection (abstract, Page 1 line 9-19, Page 19 line 1-5, Page 32 line17-19), where the diuretic like furosemide can be from about 1mg-about 200mg (Page 33 line 15-19).
Wherein it would be obvious before the effective filing date of the claimed invention to incorporate the furosemide at the recited amount as suggested by MacLaughlan and produce the claimed invention; as it is prima facie obvious to incorporate the furosemide in the composition at its known dosage range and optimize the amount to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed value.
Claims 7 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-26 of U.S. Patent No. 12403120 as applied to claims 1, 4-5, 25 above, in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the intravenous or subcutaneous administration of furosemide but does recite treating conditions like hypertension and heart failure with furosemide in a liquid composition.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of parenteral administration such as intravenous and subcutaneous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-26 of U.S. Patent No. 12403120 in view of www.pharmacorama.com (Routes of drug administration - Parenteral route) as applied to claims 7 and 10 above, further in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of patented claims in view of www.pharmacorama.com are addressed above.
The patented claims in view of www.pharmacorama.comdoes not expressly teach the patch/pump means of subcutaneous administration but does teach subcutaneous administration including subcutaneous.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
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.
Claims 1, 4-5, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 28 of U.S. Patent No. 11246851.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite limitations that fall within the breath of the instant claims and the amount of furosemide and tris in the patented claims that fall within the claimed values (about 15mg/ml-about 40mg/ml, about 25mM) and the pH embraces the claimed range 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.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 28 of U.S. Patent No. 11246851 as applied to claims 1, 4-5, 25 above, in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the patented claims are addressed above.
The patented claims does not expressly teach the isoosmolarity of the administered composition, but does teach the liquid composition for administration.
www.infusionnurse.org teaches that solutions to be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 28 of U.S. Patent No. 11246851 as applied to claims 1, 4-5, 25 above, in view of MacLaughlan (WO 96/24372).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the recited amount of furosemide but does recite treating conditions like heart failure and hypertension with furosemide at various concentrations.
MacLaughlan teaches that furosemide (diuretic) is known to be useful for hypertension and heart failure by intravenous and subcutaneous injection (abstract, Page 1 line 9-19, Page 19 line 1-5, Page 32 line17-19), where the diuretic like furosemide can be from about 1mg-about 200mg (Page 33 line 15-19).
Wherein it would be obvious before the effective filing date of the claimed invention to incorporate the furosemide at the recited amount as suggested by MacLaughlan and produce the claimed invention; as it is prima facie obvious to incorporate the furosemide in the composition at its known dosage range and optimize the amount to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed value.
Claims 7 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 28 of U.S. Patent No. 11246851 as applied to claims 1, 4-5, 25 above, in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of patented claims are addressed above.
The patented claims does not expressly teach the intravenous or subcutaneous administration of furosemide but does recite treating conditions like hypertension and heart failure with furosemide in a liquid composition.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of parenteral administration such as intravenous and subcutaneous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 28 of U.S. Patent No. 11246851 in view of www.pharmacorama.com (Routes of drug administration - Parenteral route) as applied to claims 7 and 10 above, further in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of patented claims in view of www.pharmacorama.com are addressed above.
The patented claims in view of www.pharmacorama.comdoes not expressly teach the patch/pump means of subcutaneous administration but does teach subcutaneous administration including subcutaneous.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
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 claims 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 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.
Claims 1, 4-7, 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 43-45, 62-64 of copending Application No. 19/384267 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims recite the same method with the same components in ranges that fall within the instant claims wherein there is a case of obviousness. The amount of furosemide in the copending claims either fall within the claimed values or embrace them, and pH range amount of furosemide embraces the instant claimed range wherein it is prima facie obvious to optimize within the copending range and arrive at the claimed pH values and amount/concentration of furosemide with a reasonable expectation of success absent evidence of criticality for the claimed values.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 2 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 43-45, 62-64 of copending Application No. 19/384267 (reference application) as applied to claims 1, 4-5, 7, 25 above, in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of the copending claims are addressed above.
The copending claims does not expressly teach the isoosmolarity of the administered composition, but does teach the liquid composition for administration.
www.infusionnurse.org teaches that solutions to be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 8-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 43-45, 62-64 of copending Application No. 19/384267 (reference application) as applied to claims 1, 4-5, 7, 25 above, in view of Caffey et al. (U.S. Pat. Pub. 2011/0060280).
The teachings of copending claims are addressed above.
The copending claims does not expressly teach the patch/pump means of subcutaneous administration but does teach subcutaneous administration including subcutaneous.
Caffey et al. teaches that known means of subcutaneous drug delivery includes drug-delivery devices that have a skin patch and a pump (see title and abstract). The skin patch-based delivery system is capable of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize known forms subcutaneous drug delivery such as the one with a patch and pump, as suggested by Caffey et al. with a reasonable expectation of success as it provides a means of delivering highly controlled dosages of drug at regular intervals or intermittently, depending on the needs of the patient which is desirable.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 10 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 43-45, 62-64 of copending Application No. 19/384267 (reference application) as applied to claims 1, 4-5, 7, 25 above, in view of www.pharmacorama.com (Routes of drug administration - Parenteral route).
The teachings of copending claims are addressed above.
The copending claims does not expressly teach the intravenous administration of furosemide but does recite treating conditions like hypertension and edema with furosemide at from about 40mg/ml or more and subcutaneous administration.
www.pharmacorama.com teaches that known means of administration include parenteral administration forms like intravenous and subcutaneous.
Wherein it would have been prima facie obvious before the effective filing date of the claimed invention to utilize other known forms of parenteral administration such as intravenous instead of subcutaneous as suggested by www.pharmacorama.com with a reasonable expectation of success absent evidence of criticality for the specific claimed modality.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 11, 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 43-45, 62-64 of copending Application No. 19/384267 (reference application) as applied to claims 8-9 above, in view of www.infusionnurse.org (Is there a difference? Osmolarity vs. Osmolality).
The teachings of copending claims are addressed above including that the furosemide from about 10-about 200 in a volume of about 0.5-10ml wherein the amount/concentration of furosemide is about 1-400mg/ml wherein optimization within the range to arrive at the claimed concentration/amount is prima facie obvious absent evidence criticality for the claimed value.
The copending claims does not expressly teach the isoosmolarity of the administered composition, but does teach the liquid composition for administration such as subcutaneous.
www.infusionnurse.org teaches that solutions to be isosmotic/isotonic, hypertonic (hyperosmotic, >300mOsom/L), or hypotonic (hypo-osmotic <270mOsm/L; and when isosmotic/isotonic the fluid compartments are equal = no net water movement occurs, but when hypotonic (hypo-osmotic) it will move water into the cell - causing the cell to swell and potential burst. Hypertonic/hyperosmotic solutions will cause the cell to shrink, wherein these solutions are used to replace electrolytes.
Wherein it would be prima facie obvious before the effective filing date of the claimed invention to have the solution be isosmotic as suggested by www.infusionnurse.org and produce the claimed invention; as by being isosmotic it would not affect the cells as there is no net water movement as cell rupture is undesirable (hypotonic/hypo-osmotic) and it is not delivering electrolytes wherein a hypertonic/hyperosmotic solution would not be desirable, with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 4-5, 7-10, 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-11 of copending Application No. 19/249224 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims recite the same method with the same components in ranges that fall within the instant claims wherein there is a case of obviousness.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 6, 11, 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-11 of copending Application No. 19/249224 (reference application) as applied to claims 1-2, 4-5, 7-10, 25 above, in view of MacLaughlan (WO 96/24372).
The teachings of copending claims are addressed above.
The copending claims does not expressly teach the recited amount/concentration of furosemide but does recite treating conditions like hypertension with furosemide.
MacLaughlan teaches that furosemide (diuretic) is known to be useful for hypertension and heart failure by intravenous and subcutaneous injection (abstract, Page 1 line 9-19, Page 19 line 1-5, Page 32 line17-19), where the diuretic like furosemide can be from about 1mg-about 200mg (Page 33 line 15-19).
Wherein it would be obvious before the effective filing date of the claimed invention to incorporate the furosemide at the known amounts as suggested by MacLaughlan and produce the claimed invention; as it is prima facie obvious to incorporate the furosemide in the composition at its known dosage range at various bolus volumes (i.e. 1ml) and optimize the amount (i.e. 30mg, 30mg/1ml) to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed value.
Conclusion
Claims 1-2, 4-11, 25-26 are rejected.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613