DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of group II in the reply filed on January 29, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant’s election without traverse of the species of bis(pyrazine-2-carboxylato)copper(II) (Cu(POA)2) and a sugar excipient in the reply filed on January 29, 2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Applicants also elected that “the particle comprises an aerodynamic particles size distribution (APSD) of about 2-3 microns (µm)” but no species election relating to the size of the particles was required.
Comments and Notes
In claim 14, line 4, “a antitussive” should be “an antitussive”.
Claim Rejections - 35 USC § 112 – Written Description
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 11 – 16, 18 and 19 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. This is a written description rejection.
A generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention the achieves the claimed results and do so by showing that that the applicant has invented species sufficient to support a claim to a functionally-defined genus.
Only claim 13 recites a list of metal ions and therefore the MOF can comprise any metal ion. The metal ions of the MOF can be used for some imaging modalities, based on the particular metal and isotopes of the metal that are present.
The organic ligand of the claimed metal-organic framework (MOF) containing composition is defined functionally as a compound or prodrug of a therapeutic agent with at least two metal coordination sites that “has a biological activity related to treatment of the pulmonary disease or disorder” (emphasis added). This indicates that the organic ligand is broader than substances that treat the pulmonary disease or disorder but would appear to extend to all members of the class with a relevant biological activity for pulmonary disease or disorder treatment even if that organic compound itself is not therapeutically effective against the pulmonary disease or disorder. Alternatively, the organic ligand at least two metal coordination sites and “has a property useful for biomedical imaging”. organic based molecules such a fluorophores and fluorescent proteins have properties useful for biomedical imaging. The organic ligand therefore encompasses substances with such properties that are currently unappreciated and undiscovered substances with such properties.
In addition to these properties of the individual elements, the organic ligand must also coordinate with the metal ions to form a MOF structure, indicating that even if a particular ligand possesses at least two metal coordination sites and either activity related to pulmonary disease or disorder treatment or activity related to biomedical imaging, that is not sufficient to meet the claim. The combination must result in the formation of an extended structure with a repeating pattern with subunits of a constant ratio to be considered a MOF and not all organic ligands with the required functions will be able to form a MOF with at least one metal ion. There is no discussion as to structure-function relationship for the organic ligand part to aid in determining the organic ligands and suitable metal(s) that can be paired to produce the required MOF structure.
The disclosure as filed prepare Cu(POA)2 MOFs but no other MOFs are prepared. No guidance as to a structure function relationship between organic ligands that can meet the functional definition and assemble into MOFs with one or more metal ions is set forth. Given the breadth of the possible combinations and the required structures claims, the single species prepared is insufficient to demonstrate possession of a representative number of species within the scope of the claims to fully satisfy the written description requirement.
Claims 15 and 16 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. This is a written description rejection.
Each of claims 15 and 16 require that the composition is “configured to” treat and/or diagnose a pulmonary disease or disorder (claim 15) or treat tuberculosis (claim 16) when administered by inhalation. Given the functional definitions of the ligand in claim 11, from which each of these claims ultimately depends, such a therapeutic activity would already appear to be present. But the phrasing of “configured to” indicates that some additional elements or features are required which are not disclosed in the claims or the disclosure as originally filed. For each of these claims to be a proper dependent claim, additional limitations on claim scope are required but possession of compositions configured in the manner required by each of these claims to demonstrate possession of a reasonable number of species within the scope of the claims to completely satisfy the written description requirement has not been demonstrated. With guidance as to the features(s) required to configure the claimed composition in the required manner, possession of the claimed subject matter has not been sufficiently demonstrated.
Claim Rejections - 35 USC § 112 – Scope of Enablement
Claims 11 – 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment of pulmonary diseases or disorders when a metal ion and/or organic ligand with therapeutic activity for the particular pulmonary disease or disorder is present in the MOF, does not reasonably provide enablement for the detection or diagnosis of a pulmonary disease or disorder or the treatment of pulmonary diseases or disorders when the organic ligand only has biological activity related to the pulmonary disease or disorder. The detection or diagnosis of a pulmonary disease or disorder is not enabled. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The disclosure and claims of the application have been compared per the factors indicated in the decision In re Wands, 8 USPQ2nd 1400 (Fed. Cir. 1988) as to undue experimentation
The factors include:
1. The nature of the invention;
2. The breadth of the claims;
3. The predictability or unpredictability of the art;
4. The amount of direction or guidance presented;
5. The presence or absence of working examples
6. The quantity of experimentation necessary;
7. The state of the prior art; and
8. The relative skill of those skilled in the art.
Each relevant factor is addressed below on the basis of comparison of the disclosure, the claims and the state of the art in the assessment of undue experimentation.
The nature of the invention; the breadth of the claims:
The claims are drawn to a product defined in part by the preparation process as the MOF particle must be spray dried. The only required ingredients in the claimed compositions are the metal and organic ligand with at least two metal coordination sites and activity as set forth in claim 11 that have additional issues under 35 USC 112 as discussed herein. The scope of the required metal and organic ligand that form the MOF are not clear for all but claim 17 that recites a specific metal ion (copper(II)) and organic ligand (pyrazine-2-caboxylic acid) pair that assemble into a MOF. Additionally, the composition has an intended use of a “therapeutic and/or diagnostic composition” and the MOF particles are “for treating and/or detecting a pulmonary disease or disorder”. Additional ingredients such as targeting ligands are not required to be present but are not excluded from the scope of the claims. When a compound or composition claim is limited by a particular use, enablement of that claim should be evaluated based on that limitation (MPEP 2164.01(c)).
The predictability or unpredictability of the art; the amount of direction or guidance presented; the presence or absence of working examples; the quantity of experimentation necessary; the state of the prior art; the relative skill of those skilled in the art:
The relative skill of those skilled in the art is high such as a research scientist.
The specification sets forth a single example of a MOF with metal ion and organic ligand that are known to be useful in the treatment of tuberculosis (see Durham et al. (Mol Pharmaceutics, 2015) and da Silva et al. (Int J Mol Sci, 2016) discussed in greater detail below). The breadth of the possible MOFs although not all possible combinations of metal and organic ligand will assemble in the requisite structure to form MOFs.
Based on the limitations on the organic ligand, the treatment of pulmonary diseases or conditions is enabled when the organic ligand is known to treat a particular pulmonary disease or disorder and or when the metal possesses the required activity (e.g., Cu(II) is known the be efficacious for the treatment of tuberculosis (TB)).
No imaging examples are given demonstrating how information on the distribution of the MOF particles is sufficient to detect and/or diagnose a pulmonary disease or disorder. While some metal ions can be imaged using various modalities depending on the metal and possible isotope of the metal ion present in the MOF, merely being able to image where the particles are after administration does not provide sufficient information to diagnose a particular pulmonary disease or disorder. The addition of targeting ligands, for example, to the MOFs that bind preferentially to cancer cells, that are then imaged using a suitable biomedical imaging technique, would be capable of detecting and/or diagnosing a pulmonary cancer. However, such elements are not required by the claims.
Given the large breadth of possible materials that can be used to produce MOFs, undue experimentation would be required to require which combinations treat other pulmonary diseases or disorders when the neither the metal nor the organic ligand is known to treat such a condition or either detect or diagnose any particular pulmonary disease or disorder with only the elements required by the claims.
The working examples are very narrow in scope and even for the particular copper(II)) (pyrazine-2-caboxylic acid) MOF used in the examples, there is no evidence of record that such a construct could treat infections other than those caused by bacteria such as that which causes tuberculosis and/or could detect or diagnose any pulmonary diseases or disorders.
Claim Rejections - 35 USC § 112 – Indefiniteness
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.
Claims 11 – 16,18 and 19 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 word “optionally” followed by a list of groups of metals or a particular size range renders the claim indefinite because this phrasing results in broad and narrow limitations being present. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation a metal ion, and the claim also recites a Markush group of various metal ions that is less than all metals in the periodic table which is the narrower statement of the range/limitation. Claim 1 also recites the broad recitation “an aerodynamic particle size distribution (APSD) in a range suitable for pulmonary delivery”, and the claim also recites “about 1-5 microns” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The phrase “with an aerodynamic particle size distribution (APSD) in a range suitable for pulmonary delivery” (emphasis added) is also unclear. APSD refers to a population of particles and the distribution of the aerodynamic particle sizes of the particles in the measure population and therefore is a range and not a specific value such as d50 particle size. This claimed phrase in combination with a size range is not clear as does this mean that all particles in the claimed composition must have an aerodynamic particle size within the range of 1-5 microns? Or does this phrasing mean that as long as the ASPD overall contains particles with an aerodynamic diameter falling within the range of 1-5 microns, then the composition falls within the scope of the claims?
The phrase “with an aerodynamic particle size distribution (APSD) in a range suitable for pulmonary delivery” is present in the last paragraph of claim 1 that defines the organic ligand and it is not understood how the organic ligand can have such a property. Particles of the organic ligand could have an APSD, but that would make coordination of the organic ligand with the metal ion to form the required MOF particles difficult to form and limit the amount that can be prepared due to most of the organic ligand being unavailable for coordination.
Please clarify.
The dependent claims fall therewith.
For the purposes of applying art below, the claims are being interpreted as the MOF particles have an APSD suitable for pulmonary delivery even though the claims do not link the APSD to the MOF particles themselves and only to the organic ligand.
Claim 15 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 scope of the pulmonary diseases or disorders that the composition must be configured to treat and/or diagnose is not clear. One item in the list is “any other disease or disorder treatable using an anti-asthmatic”. This appears to broaden the scope of the potential diseases or disorders beyond pulmonary diseases or disorders as long as the condition is treatable using anti-asthmatics. Asthma is a pulmonary disease or disorder but some such therapeutic agents for asthma will also be useful for non-pulmonary diseases or conditions such as relaxation of smooth muscle not only in the lung but other tissues of the body. The list of drug classes that follow this phrase do not fall within the scope of pulmonary diseases or disorders. If Applicants wish these drugs to be considered as an extension of the phrase “any other disease or disorder treatable using an anti-asthmatic”, the claim should be amended to indicate that the drugs listed are not intended as disease or disorders. However that would not fully resolve the issues with the scope of the claims as “any other disease or disorder treatable using” the long list of drugs would be indefinite.
Please clarify.
Claim 18 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 18 states that “the aerosolized formulation of the spray-dried MOF particle comprises an APSD of about 2-3 microns (µm)”. As discussed above, the APSD refers to an entire population of particles so it does not make sense to specify that the composition comprises something that describes the population of particles. While particles with an aerodynamic size in the range of 2-3 microns can be present, it is not clear how such a range is to be interpreted in relation to the claimed range and the open nature of “comprising”. Is any APSD having any particles with an aerodynamic size within the range encompassed and can contain particles of any other aerodynamic size? An average or median particle size can be determined from any given APSD that could fall within the claimed size range, but that is not how the claim is worded. Please clarify.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 11 and 13 – 18 are rejected under 35 U.S.C. 103 as being unpatentable over Durham et al. (Mol Pharmaceutics, 2015) in view of Taghipour et al. (Acta Crystal C, March 2019 issue), da Silva et al. (Int J Mol Sci, 2016), Wyszogrodzka et al. (Wyszogrodzka 2016; Drug Discov Today, 2016) and Wyszogrodzka et al. (Wyszogrodzka 2018; Pharm Res, 2018).
Durham et al. discloses spray dried aerosol particles of pyrazinoic acid (POA, also called pyrazine-2-carboxylic acid) for the treatment of tuberculosis (whole document, e.g., title). POA, which reads on an anti-infective, is the active drug form after action of the Mycobacterium tuberculosis amidase of the prodrug PZA (pyrazinamide) that leaves the cells and re-enters the cell by passive diffusion from an acidic local environment where it kills the cell after sufficient accumulation in the cell (p 2575, col 1, ¶ 2).The bacilli of TB are phagocyted by alveolar macrophages in the deep lung and targeted therapy delivery can quickly lead to a rapid onset of killing action (¶ bridging cols 1 and 2 on p 2575). Smaller particles with Da (aerodynamic diameter) in the range of 1 – 5 µm deposit deeper in the lungs and a number of studies have formulated anti-TB drgs as dry powder microparticles for pulmonary delivery (p 2575, col 2, ¶ 1). The use of POA as anti-TB therapeutic formulated as aerosol particle for peripheral deposition in the lungs for macrophage uptake for enhanced therapeutic effect were studied (p 2575, col 2, ¶¶ 2 and 3). POA particles were prepared by spray drying (p 2576, col 1, ¶ 5) and the APSD determined (p 2576, col 2, ¶ 5). Depending on the salt form, the particles had a mass median aerodynamic diameter (MMAD) of 3.29 ± 0.05 µm and 5.4 µm (¶ bridging cols 1 and 2 on p 2578, see also Figure 6). Figure 7 demonstrates the antibacterial activity of salts and at all timepoints were significantly effective in killing Mtb (p 2578, col 2, ¶ 3).
The preparation of MOFs from POA and a metal ion such as copper is not disclosed.
Taghipour et al. discloses the pyrazine is a weaker base than pyrimidine and pyridazine but all three molecules are rigid, making them ideal for the construction of MOFs (p 231). Functionalization of pyrazine units with electron-withdrawing or -donating groups such as carboxylate provide opportunities for more interactions for the construction of structures with higher dimensions (p 231). MOFs based on pyrazines can be prepared with metal ions such as copper(II) (p 237, ¶ bridging cols 1 and 2).
Pyrazine-2-carboxylic acid uses three functional group to coordinate to Cu and Co ions given the various available donor-acceptor sites that coordinate metal ions and also potential hydrogen-bonding interactions (p 241, col 2, ¶ 2).
da Silva et al. discloses the activity of copper (II) complexes in nanostructured lipid systems (NLS) against TB (whole document, e.g., title). Numerous copper(II) complexes show significant antimycobacterial activity against Mtb H37Rv (p 2, ¶ 2). Copper(II) complexes with isoniazid (INH), a drug used extensively to treat TB, have been studied but low water solubility of the metal complexes hindered drug research (p 2, ¶ 3), leading to the inclusion of the metal complexes in NLSs (p 3, ¶ 1). Improved inhibitory action against Mtb was seen compared to the compounds alone (abstract).
Wyszogrodzka 2016 discloses metal/metal oxide nanoparticle systems and MOFs have demonstrated significant antibacterial activity with an entirely different mechanism of action than antibiotics (p 1009, col 1, ¶ 1). MOFs appear promising because their active centers are inherent parts of the molecular structure with stability from the formation of chemical bonds strong enough to stabilize their form to make the material robust but weak enough not to block their activity (¶ bridging cols 1 and 2 on p 1009). The antibacterial action of the MOFs is associated with physical damage to the cells (p 1012, col 2, ¶ 1). MOFs could be used as reservoirs for metal ions with the gradual release of the metal ions by biodegradation of the framework structures providing a sustained antibacterial effect with high durability (p 1015, col 2, ¶ 2). The organic linkers used to synthesize the MOFs can themselves be antimicrobial so the metal ions and linkers could be combined or reveal synergistic effects (p 1015, col 2, ¶ 3).
Wyszogrodzka 2018 disclose the application of the MOF Fe-MIL-101 as a theranostic carrier for anti-TB drugs (whole document, e.g., abstract). MOF particles, 3.37 – 6.45 µm in size, were loaded with isoniazid and showed extended release (abstract). Pulmonary administration offers the ability to directly deliver drug to the infected macrophages in the deepest parts of the lungs and ensure a high local drug concentration avoiding the side effects of systemic drug action (p 3, col 1, ¶¶ 3 and 4).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to prepare MOFs with Cu(II) as the metal and POA as the organic ligand in a particulate form size for delivery to the deep lung for direct delivery of the therapeutic agents to TB infected macrophages of the deep lung. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because both copper(II), alone or in complexes with organic ligands, and POA are known in the art to possess anti-TB therapeutic activity. Given the disclosure of Taghipour et al. as to the rigid structure of POA (pyrazine-2-carboxylic acid), one of ordinary skill in the art would reasonably expect that Cu(II) and POA can form MOFs and would motivated to do based on the teachings of Wyszogrodzka 2106 and Wyszogrodzka 2018 as the additional benefits of MOFs for anti-bacterial uses and the additional activity such forms possess even when not prepared from inherently antibacterial materials. Such a structure would be comprised of at least two agents known to be effective against TB and the physical structure of the MOF can also provide antibacterial activity based on the structure and provide a sustained release of the copper and POA anti-TB ingredients due to biodegradation of the framework structures as taught by Wyszogrodzka 2016. The APSD and particle size determines the deposition location in the lung as Durham et al. discloses that 1 – 5 µm sized particles deposit deeper in the lungs. Therefore one of ordinary skill in the art would routinely optimize the APSD and particle size distribution to maximize the number of MOF particles that are deposited in the deep lung where TB-infected macrophages are found as taught by Wyszogrodzka 2018. The materials of Durham et al. are spray dried so materials suitable for pulmonary administration can be prepared by spray drying. There is no evidence of record that the production process results in a different and non-obvious product. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) MPEP 2113.
Claim(s) 12 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Durham et al., Taghipour et al., da Silva et al., Wyszogrodzka 2016 and Wyszogrodzka 2018 as applied to claims 1 and 13 - 18 above, and further in view of Rahimpour et al. (Drug Discov Today, 2014).
Durham et al., Taghipour et al., da Silva et al., Wyszogrodzka 2016 and Wyszogrodzka 2018 are discussed above.
The presence of sugar in the composition is not disclosed.
Rahimpour et al. that most DPIs (dry powder inhalers) are formulated as large carrier particles blended with micronized drug with aerodynamic particle diameters of 1 – 5 µm to improve the flowability of the drug particle, dosing accuracy and dose variability and the dispensing properties of cohesive dry particles during emission (p 618, col 2, ¶ 2). Lactose is the most common and frequently used in DPI formulations but cannot be used in all applications due to factors such as lactose being a reducing sugar and lactose intolerance or diabetes in the patient receiving the composition (p 618, col 1). Mannitol (p 620), trehalose (p 621, col 1, ¶ 2) and dextrose (p 621, col 2, ¶ 4) are among other sugars disclosed as suitable for use in DPI formulations.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to add a sugar such as lactose, mannitol, trehalose or dextrose to the inhalable formulations of Durham et al., Taghipour et al., da Silva et al., Wyszogrodzka 2016 and Wyszogrodzka 2018. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Rahimpour et al. discloses that the addition of sugar carriers to micronized drugs with aerodynamic particle diameters of 1 – 5 µm improve the flowability of the drug particle, dosing accuracy and dose variability and the dispensing properties of cohesive dry particles during emission. One of ordinary skill in the art can select the appropriate sugar to add based on factors such as the suitability of a reducing sugar in combination with the MOF active agent and/or the intended patient population.
Conclusion
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/Nissa M Westerberg/Primary Examiner, Art Unit 1618