DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 1-6 have been presented for examination on the merits.
Priority
This Application claims priority to the provisional Application filed on 08/23/2004.
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.
Claims 2 and 4 are 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. Claim 2 recites a rugosity of less than 1. The Specification does not provide support for a rugosity of less than 1. The Specification recites a rugosity of less than 2 and an embodiment where the rugosity is approximately 1. In claim 4 the size range for the complex is in the range of about 0.5 to about 6 microns. The Specification discloses a diameter between about 0.5 microns and 10 microns and an embodiment wherein the particle size is from 0.5 to 5.38 microns.
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 5 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.
Claim 5 is indefinite for reciting that the disodium FDKP-insulin microparticles are about 25% insulin by weight. It is not clear what “is 25%” means. for compact prosecution, this is interpreted as the microparticles comprise 25% by weight of insulin.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Steiner et al (6,071,497) in view of Staniforth et al (US 20030185764).
Steiner et al ‘497 teach a microparticulate system for drug delivery to the pulmonary system comprising synthetic biodegradable microparticles which comprise a diketopiperazine and which have a diameter between 0.5 microns and 10 microns and which release an incorporated therapeutic, prophylactic, or diagnostic agent in a pharmaceutically acceptable carrier for administration to the lungs (See abstract and claim 1).
Regarding claims 1 and 4, Steiner et al teach that the microparticles are a dry powder provided with an apparatus for administration of the microparticles to the lungs (See Col. 2, lines 25-27 and claim 6), and that "diketopiperazines" includes diketopiperazines and derivatives and modifications thereof and wherein the fumaryl diketopiperazine is most preferred for pulmonary applications (See Col. 4, lines 61-62). The therapeutic agent may be insulin (See Col. 1, lines 66-67, Col. 8, lines 64-65 and claim 11). The microparticles have a particle size diameter of from 0.5 to 10 microns and preferably from 1 to 5 micron (See Col. 1, lines 48-51).
Regarding claim 5, Steiner et al teach that using diketopiperazines, the preferred range is from 0.1% to 50% loading by weight of drug (See Col. 10, lines 1-3).
Steiner et al is silent with regards to the respirable and fine particle fractions and the rugosity of the microparticles. These are well known in the art as taught by Staniforth et al.
Staniforth et al teach dry powder formulations for inhalation into the respiratory system (See abstract).
Regarding claims 1, 2 and 4, Staniforth et al teach that the said respirable particles have diameters from 0.5 to 6 μm, and have a mean rugosity coefficient of at least 1.25 (See [0017] and [0067]).
Regarding claims 1 and 6, Staniforth et al teach that the said microparticles have a fine particle fraction of 47.2% or 49.9% (See [0142] and [0150]). It is also disclosed that the following parameters, were calculated: i) the shot weight as mean expressed as mean and relative Standard deviation (RSD) ii) the fine particle dose (FPD) which is the amount of drug found in stage 2 of TSI; iii) the emitted dose which is the amount of drug delivered from the device recovered in Stage 1+stage 2; iv) the fine particle fraction (FPF). The results in terms of aerosol performances are reported in Table 3.
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Staniforth et al do not recite the respirable dose in terms of its percentage, but disclose high performance and high respirable fraction in terms of microgram (See [00140]-[0141]).
Regarding claim 3, it is disclosed that the powder’s post-Vibration homogeneity measured as a percentage coefficient of variation, after being subjected to the described test, is less than about 5% can be regarded as acceptable (See [0071]).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Staniforth et al with of Steiner et al ‘497 to arrive at the instant invention. It would have been obvious to do so because both references teach dry powder comprising an active agent including insulin for inhalation to the respiratory system. Steiner et al’s teachings would have motivated one of ordinary skill in the art to have combined insulin with fumaryl diketopiperazine to make microparticles for effective delivery to the lungs because it is disclosed that combining insulin with FDKP is advantageous in providing an improved composition for drug delivery in to the pulmonary system and for controlled pulsed or sustained administration of a drug including insulin. Steiner et al also provide guidance on particle specifics for their effective inhalation including particle size and amount. One of ordinary skill in the art would have been motivated to have looked in the art for other beneficial particle specifics including rugosity of fine/ respirable fraction as taught by Staniforth et al with a reasonable expectation of improving the dosage form and delivery of Steiner et al.
In other words, the claims would have been obvious because the technique for improving a particular formulation was part of the ordinary capabilities of a person of ordinary skill in the art, in view of the teaching of the technique for improvement in other situations.
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 1-6 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Steiner et al (6,652,885) in view of Staniforth et al (US 20030185764).
Steiner et al ‘885 teach methods for purifying peptides and proteins by incorporating the peptide or protein into a diketopiperazine or competitive complexing agent to facilitate removal one or more impurities, i.e. undesirable components, from the peptide or protein. The said peptide is insulin, (See abstract and claim 1).
Regarding claims 1 and 4, it is disclosed that the said diketopiperazine is fumaryl diketopiperazine, and wherein the composition is in a dry powder form administered to the lungs via inhalation. In a preferred embodiment, insulin is administered via the pulmonary delivery of microparticles comprising fumaryl diketopiperazine and insulin in its biologically active form (See abstract, Col. 3, lines 29-39, and claims 2-3). The said microparticles are so produced to have a mean diameter of between about 1 and about 5 microns (See Col. 12, lines 65-67).
Regarding claim 5, it is disclosed that using diketopiperazines, the preferred range of the drug loading is from 0.1% to 50% by weight. The appropriate dosage can be determined, for example, by the amount of incorporated/encapsulated agent, the rate of its release from the microparticles, and, in a preferred embodiment, the patient's blood glucose level (See Col. 11, lines 4-12).
Steiner et al is silent with regards to particle specifics inlcudi9ng rugosity, fine particle fraction, coefficient of variation and respirable fraction. These are well known in the art as taught by Staniforth et al.
Staniforth et al’s teachings are delineate above and incorporated herein.
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Staniforth et al with of Steiner et al ‘885 to arrive at the instant invention. It would have been obvious to do so because both references teach dry powder comprising an active agent including insulin for inhalation to the respiratory system. Steiner et al’s teachings would have motivated one of ordinary skill in the art to have combined insulin with fumaryl diketopiperazine to make microparticles for effective delivery to the lungs because it is disclosed that combining insulin with FDKP is advantageous in removing impurities and improved transport of the said active agent to the target site. Steiner et al also provide guidance on particle specifics for their effective inhalation including particle size and amount. One of ordinary skill in the art would have been motivated to have looked in the art for other beneficial particle specifics including rugosity of fine/ respirable fraction as taught by Staniforth et al with a reasonable expectation of improving the dosage form and delivery of Steiner et al.
In other words, the claims would have been obvious because the technique for improving a particular formulation was part of the ordinary capabilities of a person of ordinary skill in the art, in view of the teaching of the technique for improvement in other situations.
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
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 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7-8, 11, 13-15 and 19 of U.S. Patent No. 9,259,471 in view of Staniforth et al (US 20030185764). An obviousness-type double patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims because the examined claims would have been obvious over the reference claims in view of Staniforth et al.
Specifically, the examined claims are related to a dry powder composition comprising: disodium fumaryl diketopiperazine (FDKP) particles chemically associated with insulin to form a disodium FDKP-insulin microparticle complex; wherein the disodium FDKP-insulin microparticle complex is defined as having an average respirable fraction of 88% with a Standard Deviation of 1.60, a size range of between about 0.5 μm to about 10 μm, and a rugosity of less than 2.
Reference claim 1 is directed to a microparticulate system for drug delivery comprising a composition comprising: microparticles of a pharmaceutically acceptable anion of a diketopiperazine compound comprising a carboxylate group, a divalent cation, and a biologically active agent, wherein the diketopiperazine compound is represented by the following general formula:
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wherein E1 and E2 are NH, and R1 and R2 are independently selected from succinate-4-aminobutyl, glutarate-4-aminobutyl, maleate-4-aminobutyl, citraconate-4-aminobutyl, malonate-4-aminobutyl, oxalate-4-aminobutyl, and fumarate-4-aminobutyl.in claim 7, the diketopiperazine compound is fumaryl diketopiperazine. In claims 3 and 13, the biologically active agent is insulin. In claims 8 and 15, the particle size is from 0.5 to 10 microns.
The differences include rugosity, respirable and fine particle fraction and the amount of insulin in the microparticles. These are known in the art as taught by Staniforth et al. Staniforth et al teach inhalable powder formulations comprising insulin and wherein the powder has respirable particle size, respirable fraction and an acceptable rugosity.
Thus, it would have been obvious to one of ordinary skill in the art to have combined the teachings of Staniforth et al on effective powders for inhalation into the claims of the reference application to arrive at the claimed invention with a reasonable expectation of success.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 11-12 and 15 of U.S. Patent No. 8,653,085 in view of Staniforth et al (US 20030185764). An obviousness-type double patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims because the examined claims would have been obvious over the reference claims in view of Staniforth et al.
Specifically, the examined claims are related to a dry powder composition comprising: disodium fumaryl diketopiperazine (FDKP) particles chemically associated with insulin to form a disodium FDKP-insulin microparticle complex; wherein the disodium FDKP-insulin microparticle complex is defined as having an average respirable fraction of 88% with a Standard Deviation of 1.60, a size range of between about 0.5 μm to about 10 μm, and a rugosity of less than 2.
Reference claim 1 is directed to a microparticulate system for drug delivery comprising a composition comprising: microparticles of a pharmaceutically acceptable anion of a heterocyclic compound and a biologically active agent, wherein said microparticles release a biologically active agent; and a cation; wherein said anion is 3,6-di(fumarate-4-aminobutyl)-2,5-diketopiperazine. In claim 3, the biologically active agent is insulin. In claims 6 and 12, the particle size is from 0.5 to 10 microns.
The differences include rugosity, respirable and fine particle fraction and the amount of insulin in the microparticles. These are known in the art as taught by Staniforth et al. Staniforth et al teach inhalable powder formulations comprising insulin and wherein the powder has respirable particle size, respirable fraction and an acceptable rugosity.
Thus, it would have been obvious to one of ordinary skill in the art to have combined the teachings of Staniforth et al on effective powders for inhalation into the claims of the reference application to arrive at the claimed invention with a reasonable expectation of success.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7, 9 and 13 of U.S. Patent No. 8,278,308 in view of Staniforth et al (US 20030185764). An obviousness-type double patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims because the examined claims would have been obvious over the reference claims in view of Staniforth et al.
Specifically, the examined claims are related to a dry powder composition comprising: disodium fumaryl diketopiperazine (FDKP) particles chemically associated with insulin to form a disodium FDKP-insulin microparticle complex; wherein the disodium FDKP-insulin microparticle complex is defined as having an average respirable fraction of 88% with a Standard Deviation of 1.60, a size range of between about 0.5 μm to about 10 μm, and a rugosity of less than 2.
Reference claim 1 is directed to a method for delivery of a biologically active agent comprising: administering to a patient in need of treatment therewith an effective amount of a biologically active agent in the form of microparticles, said microparticles comprising a pharmaceutically acceptable salt of a diketopiperazine and the biologically active agent; wherein said microparticles release said biologically active agent upon administration; and wherein the diketopiperazine compound is fumaryl diketopiperazine. In claims 3 and 13, the biologically active agent is insulin. In claim 7, the particle size is from 0.5 to 10 microns.
The differences include rugosity, respirable and fine particle fraction and the amount of insulin in the microparticles. These are known in the art as taught by Staniforth et al. Staniforth et al teach inhalable powder formulations comprising insulin and wherein the powder has respirable particle size, respirable fraction and an acceptable rugosity.
Thus, it would have been obvious to one of ordinary skill in the art to have combined the teachings of Staniforth et al on effective powders for inhalation into the claims of the reference application to arrive at the claimed invention with a reasonable expectation of success.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-8 and 10 of U.S. Patent No. 7,820,676 in view of Staniforth et al (US 20030185764). An obviousness-type double patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims because the examined claims would have been obvious over the reference claims in view of Staniforth et al.
Specifically, the examined claims are related to a dry powder composition comprising: disodium fumaryl diketopiperazine (FDKP) particles chemically associated with insulin to form a disodium FDKP-insulin microparticle complex; wherein the disodium FDKP-insulin microparticle complex is defined as having an average respirable fraction of 88% with a Standard Deviation of 1.60, a size range of between about 0.5 μm to about 10 μm, and a rugosity of less than 2.
Reference claim 1 is directed to a dry powder therapeutic composition comprising: a pharmaceutically acceptable anion of a heterocyclic compound according to Formula 1:
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wherein R1 and/or R2 comprise a terminal carboxlate functional group and E1 and E2 are NH such that said anion is selected from the group consisting of 3,6-di(succinate-4-aminobutyl)-2,5-diketopiperazine, 3,6-di(maleate-4-aminobutyl)-2,5-diketopiperazine, 3,6-di(fumarate-4-aminobutyl)-2,5-diketopiperazine and 3,6-di(glutamate-4-aminobutyl)-2,5-diketopiperazine; and at least one cation; and a biologically active agent; and wherein said dry powder therapeutic composition is formed by spray drying. In claim 3 the biologically active agent is insulin. In claim 6, the particle size is from 0.5 to 10 microns. In claim 10 the diketopiperazine compound is fumaryl diketopiperazine. In claim 8, the rugosity is less than 2.
The reference claims differ from examined claims in that they do not expressly recite respirable and fine particle fraction and the amount of insulin in the microparticles. These are known in the art as taught by Staniforth et al. Staniforth et al teach inhalable powder formulations comprising insulin and wherein the powder has respirable particle size, respirable fraction and guidance on the amount of active agent.
Thus, it would have been obvious to one of ordinary skill in the art to have combined the teachings of Staniforth et al on effective powders for inhalation into the claims of the reference application to arrive at the claimed invention with a reasonable expectation of success.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10-18 of U.S. Patent No. 11,872,265 in view of Steiner et al (6,071,497) and Staniforth et al (US 20030185764). An obviousness-type double patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims because the examined claims would have been obvious over the reference claims in view of Steiner et al and Staniforth et al.
Specifically, the examined claims are related to a dry powder composition comprising: disodium fumaryl diketopiperazine (FDKP) particles chemically associated with insulin to form a disodium FDKP-insulin microparticle complex; wherein the disodium FDKP-insulin microparticle complex is defined as having an average respirable fraction of 88% with a Standard Deviation of 1.60, a size range of between about 0.5 μm to about 10 μm, and a rugosity of less than 2.
Reference claim 1 is directed to a method for the delivery of particles to the pulmonary system comprising: administering to a patient in need of treatment an effective amount of a dry powder composition by inhalation, the dry powder composition comprising: a phosphodiesterase type 5 (PDE5) inhibitor; and a pharmaceutically acceptable salt of a heterocyclic compound which has a structure according to Formula 1:
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wherein R1 or R2 are independently selected from 4-succinyl-aminobutyl, 4-glutaryl-aminobutyl, 4-maleyl-aminobutyl, 4-fumaryl-aminobutyl, 4-citraconyl-aminobutyl, 4-malonyl-aminobutyl, 4-oxalyl-aminobutyl; E1 and E2 are NH; and said salt further comprises a cation. In claim 10, the microparticles are in a dry powder form. In claims 13-14 the particle size is less than 5 microns. In claims 12 and 15, the rugosity is less than 2.
The reference claims differ from examined claims in that they do not expressly disclose insulin as the active agent, and they do not recite respirable and fine particle fraction and the amount of insulin in the microparticles. These are known in the art as taught by Steiner et al and Staniforth et al. Steiner et al is directed to microparticles comprising an active agent and FDKP. Steiner et al discloses that the active agent can be any active agent including vasoactive agents, neuroactive agents, hormones, anticoagulants, immunomodulating agents, cytotoxic agents, antibiotics, antivirals, antisense, antigens, and antibodies. Staniforth et al teach inhalable powder formulations comprising insulin and wherein the powder has respirable particle size, respirable fraction and guidance on the amount of active agent. In claim 3 the biologically active agent is insulin
Thus, it would have been obvious to one of ordinary skill in the art to have combined the teachings of Steiner et al and Staniforth et al on effective powders for inhalation comprising any active agent including insulin or PDE5 into the claims of the reference application to arrive at the claimed invention with a reasonable expectation of success.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10-18 of U.S. Patent No. 10,912,821 in view of Steiner et al (6,071,497) and Staniforth et al (US 20030185764). An obviousness-type double patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims because the examined claims would have been obvious over the reference claims in view of Steiner et al and Staniforth et al.
Specifically, the examined claims are related to a dry powder composition comprising: disodium fumaryl diketopiperazine (FDKP) particles chemically associated with insulin to form a disodium FDKP-insulin microparticle complex; wherein the disodium FDKP-insulin microparticle complex is defined as having an average respirable fraction of 88% with a Standard Deviation of 1.60, a size range of between about 0.5 μm to about 10 μm, and a rugosity of less than 2.
Reference claim 1 is directed to a dry powder composition comprising: a phosphodiesterase type 5 (PDE5) inhibitor; and a pharmaceutically acceptable salt of a heterocyclic compound which has a structure according to Formula 1:
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wherein R1 or R2 are independently selected from 4-succinyl-aminobutyl, 4-glutaryl-aminobutyl, 4-maleyl-aminobutyl, 4-fumaryl-aminobutyl, 4-citraconyl-aminobutyl, 4-malonyl-aminobutyl, 4-oxalyl-aminobutyl; E1 and E2 are NH; and said salt further comprises a cation. In claim 13 the particle size is less than 5 microns. In claims 12 and 15, the rugosity is less than 2.
The reference claims differ from examined claims in that they do not expressly disclose insulin as the active agent, and they do not recite respirable and fine particle fraction and the amount of insulin in the microparticles. These are known in the art as taught by Steiner et al and Staniforth et al. Steiner et al is directed to microparticles comprising an active agent and FDKP. Steiner et al discloses that the active agent can be any active agent including vasoactive agents, neuroactive agents, hormones, anticoagulants, immunomodulating agents, cytotoxic agents, antibiotics, antivirals, antisense, antigens, and antibodies. Staniforth et al teach inhalable powder formulations comprising insulin and wherein the powder has respirable particle size, respirable fraction and guidance on the amount of active agent. In claim 3 the biologically active agent is insulin
Thus, it would have been obvious to one of ordinary skill in the art to have combined the teachings of Steiner et al and Staniforth et al on effective powders for inhalation comprising any active agent including insulin or PDE5 into the claims of the reference application to arrive at the claimed invention with a reasonable expectation of success.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent Nos. 10,583,176; 10,130,685; 9,675,674 in view of Steiner et al (6,071,497) and Staniforth et al (US 20030185764). An obviousness-type double patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims because the examined claims would have been obvious over the reference claims in view of Steiner et al and Staniforth et al.
Specifically, the examined claims are related to a dry powder composition comprising: disodium fumaryl diketopiperazine (FDKP) particles chemically associated with insulin to form a disodium FDKP-insulin microparticle complex; wherein the disodium FDKP-insulin microparticle complex is defined as having an average respirable fraction of 88% with a Standard Deviation of 1.60, a size range of between about 0.5 μm to about 10 μm, and a rugosity of less than 2.
Reference claims are drawn to similar formulation comprising different active agents. The reference claims also do not expressly disclose some of the particle specifics such as fine particle fraction or rugosity. Steiner et al teach that any active agent can e combined into microparticles with FDKP and administered to a subject via inhalation. Staniforth et al teach effective powders for inhalation and disclose guidance on the particle size, rugosity fine particle fraction, respirable fractions and amounts.
Thus, it would have been obvious to one of ordinary skill in the art to have combined the teachings of Steiner et al and Staniforth et al on effective powders for inhalation comprising any active agent including insulin, PDE5, etc; into the claims of the reference application to arrive at the claimed invention with a reasonable expectation of success.
Due to the large number of patents, they have been grouped together.
Claims 1-6 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mina Haghighatian whose telephone number is (571)272-0615. The examiner can normally be reached M-F, 7-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X. Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616