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 .
DETAILED ACTION
Claims 21-35 and 37-40 are currently pending and an amendment to the claims filed on 07/02/2026 is acknowledged. A replacement of abstract is also acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/09/2026 was filed before the mailing date of the instant action on the merits. The submissions thereof are in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statements have been considered by the examiner and signed and initialed copies are enclosed herewith.
Withdrawn rejections:
Applicant's amendments and arguments filed 07/02/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
The following rejection and/or objection are either reiterated or newly applied. They constitute the complete set of rejection and/or objection presently being applied to the instant application.
New Grounds of Rejections --- as necessitated by amendment
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 21-35 and 37-40 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.
MPEP § 2163.II.A.3.(b) states, “when filing an amendment an applicant should show support in the original disclosure for new or amended claims” and “[i]f the originally filed disclosure does not provide support for each claim limitation, or if an element which applicant describes as essential or critical is not claimed, a new or amended claim must be rejected under 35 U.S.C. 112, para. 1, as lacking adequate written description”. According to MPEP § 2163.I.B, “While there is no in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure” and “The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117”.
Each of instant claims 21, 28 and 35 recites the features “particles of the dry powder composition comprise substantially uniform loading of the insoluble or slightly soluble component” (claim 21), “particles of the dry powder composition comprise substantially uniform loading of the lipophilic component” (claim 28), and “particles of the dry powder composition comprise substantially uniform loading of the one or both of a plant-derived cannabinoid drug substance and a synthesized cannabinoid drug substance” (claim 35).
However, those features as claimed do not appear to be supported by the originally filed application because the specification simply discloses “granules offering homogenous drug distribution throughout the powder ([0075]) and previous claim 24); and that is, there is question whether uniform loading of the component is always obtained from the homogenously distributed component in the powder composition. A person skilled in the art, reading the feature “homogenous drug distribution throughout the powder” in the context of the entire specification, directly and unambiguously understands that the component is substantially uniformly distributed among/within the particles? It appears that the feature “component is homogenously distributed throughout the dry powder composition” does not automatically disclose every possible limitation that could be associated with “homogenous”; here, “the component is homogenously distributed throughout the dry powder” does not always guarantee “substantially every individual particles has substantially the same component loading”. Thus, the specification does not describe the claimed limitation in such full, clear, concise and exact terms so as to indicate that Applicant has possession of the limitation at the time of filing the present application. Thus, the written description requirement has not been satisfied.
The remaining claims are also rejected due to the rejections of base claims 21, 28 and 35.
If applicant disagrees, please provide supportive location and/or reasonable explanation.
Withdrawn rejections:
Applicant's amendments and arguments filed 07/02/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
The following rejection and/or objection are either reiterated or newly applied. They constitute the complete set of rejection and/or objection presently being applied to the instant application.
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.
Claims 21, 22, 24 and 25 are rejected under 35 U.S.C. 103 as being obvious over Gordon et al. (US2002/0132011A1) in view of Trofast (US6,287,540B1) and Weickert et al. (US2002/0177562A1).
Applicant claims the below claim 21 filed on 07/19/2024:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical dry powder research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Gordon discloses dry powders having hydrophobic and hydrophilic components (abstract); the hydrophobic components include budesonide, testosterone, hydrocortisone, prednisone (claim 9 of prior art), peptide, retinoid, vitamin D, E, K, prostaglandin, THC (tetrahydrocannabinol), hydrophobic antibiotic, and chemotherapeutic drug (claim 10 of prior art); the hydrophilic component includes lactose, pectin, etc. (claim 12 of prior art); and the dry powders are pulmonary delivered via a dry powder inhaler (DPI) (e.g., [0002], [0004], [0019], [0024], Fig. 6, etc.). The dry powders has uniform distribution prepared by spray drying method (e.g., abstract and [0009] and [0016]), and the dried powder composition having excipients enhance the uniform pulmonary delivery (e.g., [0027]).
In the below embodiment ([0060] - Table 2: e.g., formulation B-38), Gordon discloses a dry powder contains budesonide 187.5mg (= about 1.1% - obtained from 187.5mg/1562.5mg) which reads on the claimed insoluble component or slightly soluble component and its amount is within the claimed range of between about 0.01 and 50%, and lactose which reads on the claimed disaccharide and/or bulking agent as supported by instant publication at [0073], and the powder composition contains 0.81% moisture content which is within the claimed moisture content below about 10%, and therefore, the dry powder of Gordon reads on the claimed flowable dry powder (instant claim 21, in part); and the powder has a mass median aerosol diameter (MMAD) of 2.41 microns which is within the claimed range of between 0.5 and 5 microns (instant claim 25).
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The dry powder has uniform distribution prepared by spray drying method (e.g., abstract and [0009] and [0016]), and the dried powder composition having excipients enhance the uniform pulmonary delivery (e.g., [0027]).
Further, Gordon discusses the hydrophobic drug includes THC (claim 9 of prior art) which reads on the claimed cannabinoid; and such drug can be present in an amount of 0.01 to 95% ([0014]) which overlaps the instant range of about 0.01% and 50%. MPEP 2144.05 : “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).”(instant claim 22); and the dry particles produced by spray drying method has a uniform size distribution with a mean particle size below 5 microns ([0009]), and although Gordon does not expressly teach a mean granule diameter between 0.05 mm and 3 mm of instant claim 24, the granule size is generally larger than the micronized powder particle size, and therefore, the size of granule would be milled or optimized to obtain desired powder particle size as a matter of design or choice depending on the intended purpose, formulation type (e.g., powder), spray-drying technique, etc. It is also noted that since it has been held that changing the size or range of an article is not ordinarily a matter of invention, appropriate selection of size, weight, ratios, etc. is considered routine, and is typically a matter of design choice. See In re Rose 105 USPQ 237 (CCPA 1955) and also In re Yount (36 C.C.P.A. (Patents) 775, 171 F.2d 317, 80 USPQ 141(instant claim 24).
Gordon does not expressly teach the component is homogeneously distributed throughout the dry powder composition such that particles of the dry powder composition comprise substantially uniform loading of the insoluble or slightly soluble component of instant claim 21. The deficiencies are cured by Trofast and Weickert.
Trofast discloses formulation for inhalation (title) and the formulation is provided in the form of dry powder composition that comprises one or more potent active substances and a carrier substance, all of which are in finely divided form; the active substances include beclomethasone dipropionate (BDP), beclomethasone monopropionate (BMP), flunisolide, triamcinolone acetonide, fluticasone propionate, ciclesonide, budesonide, rofleponide or derivatives thereof, momethasone, tipredane, RPR 106541 and/or a β2-agonist such as terbutaline, salbutamol, formoterol, salmeterol, TA 2005, pircumarol or a pharmaceutically acceptable salt thereof; and/or a prophylactic agent such as sodium chromoglycate or nedocromil sodium (col.1, lines 37-54 and claims 4-6 of prior art); the carrier includes e.g., lactose, glucose, raffinose … starch (col. and claims 9-10 of prior art); the active substance and carrier substance are substantially uniformly distributed in the dry powder composition through remicronization step which does not disturb the crystallinity of the fine particles (col.1, line 64- col. 2, line 2, the Examples and claim 1 of prior art). The powder has a bulk density of 0.28 to 0.38 g/ml (abstract) (instant claim 21).
Weickert discloses pulmonary delivery of polyene antifungal agents, but which typically provides a uniform distribution of formulation components in the resulting, spray-dried particles (meaning that each of the particles in the final spray-dried formulation possesses substantially the same chemical composition and distribution of components within the particle) ([0088]). Therefore, since the spray-dried formulation possesses substantially the same chemical composition and distribution of components, uniform drug loading among the particles is provided as taught/suggested by Weickert.
It would have been obvious to modify the teachings of Gordon with homogenous distribution of component in the dry powder composition of Trofast and uniform loading due to same chemical composition and distribution of Weichert in order to enhance safety and performance of the dry powder.
In view of the foregoing, instant claims 21, 22, 24 and 25 are obvious over Gordon in view of Trofast and Weickert.
Claims 23 and 26-27 are rejected under 35 USC 103 as being obvious over Gordon et al. (US2002/0132011A1) in view of Trofast (US6,287,540B1) and Weickert et al. (US2002/0177562A1) and further in view of Whitfield et al. (US2010/0316724A1).
However, Gordon/Trofast/Weickert do not expressly teach nicotine of instant claim 23; fine particle fraction (FPT) and delivery efficiency (DE) of instant claim 26; and tap density of dry powder of instant claim 27. The deficiencies are cured by Whitfield.
Whitfield discloses microparticles in the form of free-flowing dry powder ([0029] and [0205]) having a moisture content of less than about 5% ([0151]) for the treatment of asthma, chronic obstructive pulmonary disease (COPD), and other lung disease ([0054]); and the microparticles contain as therapeutic agent tacrolimus, cyclosporin, cannabinoid, budesonide, nicotine, etc. ([0089]) which reads on the claimed insoluble or slightly soluble component nicotine, and polysaccharide such as lactose, trehalose, raffinose, or cyclic oligosaccharides such as cyclodextrins ([0065]); and the microparticles has a fine particle fraction (FPF) of less than 6.5 or 5.8 microns that reads on the claimed FPF, which is from about 70 or 80-90% of the delivered dose ([0188]-[0189]) that overlaps the instant delivery efficiency (DE) range of greater than 60%. MPEP 2144.05 above. (instant claim 26); and the microparticles have a tap density of less than or equal to about 0.3g/cm3 (abstract, [0041] and [0159]) which overlaps the instant range of between about 0.1 g/cm3 and 0.6 g/cm3. MPEP 2144.05 above (instant claim 27). Such low density of the microparticles can provide less weight for the same volume and therefore allow a low dose to be provided in a container without a carrier ([0208]) and additionally gives rise to plugs aerosolized in an inhaler with far greater friability than those obtained with the standard formulation friable plugs ([0280]-[0281]).
It would have been obvious to modify the teachings of Gordon/Trofast/Weickert with addition of nicotine and parameters of FPF/DE and tap density of Whitfield.
One of the ordinary artisan would have been motivated to do so because both references are directed to providing free-flowing dry powder for e.g., pulmonary drug delivery and require the similar ingredients of cannabinoid, steroid, nicotine, lactose, etc. and they are in analogous art; and accordingly, replacing or defining insoluble or slightly soluble component including THC of Gordon with nicotine would be a matter of choice or design depending on the intended purpose and thus selection of nicotine would be obvious from the standpoint of the ordinary artisan’s skill and knowledge; combining FPF/DE of Whitfield art would provide enhanced delivery because when greater than 60% of the powder’s mass consists of fine particles having less than 5.8 microns, such small particle range is enough to reach the lower airways and lungs when delivered, and combining low tap density of Whitfield with Gordon would allow less weight for the same volume and therefore a low dose without carrier as taught by Whitfield.
In light of the foregoing, instant claims 23 and 26-27 are obvious over Gordon/Trofast/Weickert in view of Whitfield.
Claims 28-34 are rejected under 35 USC 103 as being obvious over Gordon et al. (US2002/0132011A1) in view of Trofast (US6,287,540B1) and Weickert et al. (US2002/0177562A1) and further in view of Whitfield et al. (US2010/0316724A1).
Level of Ordinary Skill in the Art (MPEP 2141.03) as noted above.
Applicant claims the below claim 28 filed on 07/02/2026:
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Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Gordon discloses dry powders having hydrophobic and hydrophilic components (abstract); the hydrophobic components include steroid such as budesonide, testosterone, hydrocortisone, prednisone (claim 9 of prior art), peptide, retinoid, vitamin D, E, K, prostaglandin, hydrophobic antibiotic, and chemotherapeutic drug, THC (tetrahydrocannabinol), (claim 10 of prior art) which reads on the claimed lipophilic component; the hydrophilic component includes lactose which reads on the claimed disaccharide, pectin, etc. (claim 12 of prior art), and hydrophobic component such as hydrophobic drug is present in an amount of about 0.01 to about 95% or about 0.05 to about 25% ([0032]) which overlaps or is within the instant range of between about 0.01 and 50% of lipophilic component. MPEP 2144.05 : “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).”; the dry powders have a moisture content of below 10%, 5%, 3% or lower ([0030]) which is identical to the claimed moisture content of below 10% (instant claim 28, in part and instant claims 31-32); and the dry powders are pulmonary delivered via a dry powder inhaler (DPI) (e.g., [0002], [0004], [0019], [0024], Fig. 6, etc.); further the hydrophobic component includes cyclosporin, budesonide, fluticasone, vitamin E (=tocopherol), amphotericin B ([0026]), etc. which reads on the claimed lipophilic component species(instant claim 29); and the dry powder composition further comprises sodium citrate ([0009]) which reads on the claimed stabilizing additive (instant claim 34). The dry powders has uniform distribution prepared by spray drying method (e.g., abstract and [0009] and [0016]), and the dried powder composition having excipients enhance the uniform pulmonary delivery (e.g., [0027]).
Gordon does not expressly teach the component is homogeneously distributed throughout the dry powder composition such that particles of the dry powder composition comprise substantially uniform loading of lipophilic component of instant claim 28; and other carrier such as mannitol, trehalose, raffinose or mannitol of instant claim 32. The deficiencies are cured by Trofast and Weickert.
Trofast discloses formulation for inhalation (title) and the formulation is provided in the form of dry powder composition that comprises one or more potent active substances and a carrier substance, all of which are in finely divided form; the active substances include beclomethasone dipropionate (BDP), beclomethasone monopropionate (BMP), flunisolide, triamcinolone acetonide, fluticasone propionate, ciclesonide, budesonide, rofleponide or derivatives thereof, momethasone, tipredane, RPR 106541 and/or a β2-agonist such as terbutaline, salbutamol, formoterol, salmeterol, TA 2005, pircumarol or a pharmaceutically acceptable salt thereof; and/or a prophylactic agent such as sodium chromoglycate or nedocromil sodium (col.1, lines 37-54 and claims 4-6 of prior art); the carrier includes e.g., lactose, glucose, raffinose … starch (col. and claims 9-10 of prior art); the active substance and carrier substance are substantially uniformly distributed in the dry powder composition through remicronization step and does not disturb the crystallinity of the fine particles (col.1, line 64- col. 2, line 2, the Examples and claim 1 of prior art). The powder has a bulk density of 0.28 to 0.38 g/ml (abstract) (instant claims 28 and 32).
Weickert discloses pulmonary delivery of polyene antifungal agents, but which typically provides a uniform distribution of formulation components in the resulting, spray-dried particles (meaning that each of the particles in the final spray-dried formulation possesses substantially the same chemical composition and distribution of components within the particle) ([0088]). Therefore, since the spray-dried formulation possesses substantially the same chemical composition and distribution of components, it would be obvious to provide uniform drug loading among the particles as taught/suggested by Weickert.
It would have been obvious to modify the teachings of Gordon with homogenous distribution of component in the dry powder composition of Trofast and uniform loading due to same chemical composition and distribution of Weickert in order to enhance safety and performance of the dry powder.
It would have been obvious to modify the teachings of Gordon with certain additives including saccharide additives of Trofast in order to enhance the properties of the dry powder composition.
However, Gordon/Trofast/Weickert do not expressly teach a tap density of instant claim 28; other species of instant claim 29; nicotine of instant claim 30; and specific amino acid of instant claim 33; and other species of stabilizing additive of instant claim 34. The deficiencies are cured by Whitfield.
Whitfield discloses microparticles in the form of dry powder ([0029]) having a moisture content of less than about 5% ([0151]); the microparticles has a tap density of less than or equal to about 0.3g/cm3 (abstract and [0041]) which overlaps the instant range of greater than about 0.2 g/cm3 (instant claim 28 – tap density); the microparticles contain tacrolimus, cyclosporin, cannabinoid, budesonide, nicotine, etc. ([0089]) which reads on the claimed lipophilic component nicotine (instant claims 29-30); buffer such as citrate ([0146]), carriers, excipients or bulking agent ([0055]) such as mannitol or trehalose ([0075]), raffinose ([0106]), etc., which reads on the claimed one or more additive (instant claim 32); and the microparticles contain amino acid such as leucine, phenylalanine, tryptophan, etc. ([0074], [0089], and [0225]) which reads on the claimed amino acid(instant claim 33), and surfactants ([0146] and [0203]) including lecithin or phospholipid (e.g., DPPC) ([0237]), fatty acids, phosphatidylcholine, etc. ([0227]) which reads on the claimed stabilizing additive (instant claim 34).
It would have been obvious to modify the teachings of Gordon/Trofast/Weickert with a tap density of Whitfield because those references are directed to providing free-flowing dry powder for e.g., inhalation and require the similar ingredients of cannabinoid, steroid, nicotine, additive, etc. and they are in analogous art; and accordingly, combining low tap density of Whitfield art would provide less weight for the same volume and therefore allow a low dose without carrier as taught by Whitfield.
It would have been obvious to modify the teachings of Gordon with certain additives including amino acid, saccharide additive, and stabilizing agent of Whitfield in order to enhance the properties of the dry powder composition.
In light of the foregoing, instant claims 28-34 are obvious over Gordon/Trofast/Weickert and further in view of Whitfield.
Claims 35, 38 and 40 are rejected under 35 USC 103 as being obvious over Gordon et al. (US2002/0132011A1) in view of of Trofast (US6,287,540B1) and Weickert et al. (US2002/0177562A1).
Level of Ordinary Skill in the Art (MPEP 2141.03) as noted above.
Applicant claims the below claim 35filed on 07/02/2026:
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For examination purpose, please note that “plant derived or synthesized” cannabinoid is a product-by-process limitation which is not limiting because the “patentability of a product does not depend on its method of production.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, when the prior art teaches “cannabinoid”, it reads on the claimed cannabinoid.
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Gordon discloses dry powders having hydrophobic and hydrophilic components (abstract); the hydrophobic components include steroid such as budesonide, testosterone, hydrocortisone, prednisone (claim 9 of prior art), peptide, retinoid, vitamin D, E, K, prostaglandin, THC (tetrahydrocannabinol), hydrophobic antibiotic, and chemotherapeutic drug (claim 10 of prior art) which reads on the claimed cannabinoid component; the hydrophilic component includes lactose which reads on the claimed disaccharide, pectin, etc. (claim 12 of prior art), and the hydrophobic drugs in the dry powder composition are present in an amount of about 0.01 to about 95% or about 0.05 to about 25% ([0032]) which overlaps or within the instant range of between about 0.01 and 50% of one or both of natural and synthetic cannabinoid drug substance component; the dry powders have a moisture content of below 10%, 5%, 3% or lower ([0030]) which is identical to the claimed moisture content of below 10% (instant claim 35 (in part)); and the dry powders have a particle size of below 10 microns or preferably below 5 microns ([0016]); and the powder has a mean geometric diameter of from below 10 microns or preferably below 5 microns ([0016] and [0028]) which is within the instant range of from 0.01 to about 20 microns (instant claim 38).
However, Gordon does not expressly teach the component is homogeneously distributed throughout the dry powder composition such that particles of the dry powder composition comprise substantially uniform loading of cannabinoid component of instant claim 35; and bulk density of instant claim 40. The deficiencies are cured by Trofast and Weickert.
Trofast discloses formulation for inhalation (title) and the formulation is provided in the form of dry powder composition that comprises one or more potent active substances and a carrier substance, all of which are in finely divided form; the active substances include beclomethasone dipropionate (BDP), beclomethasone monopropionate (BMP), flunisolide, triamcinolone acetonide, fluticasone propionate, ciclesonide, budesonide, rofleponide or derivatives thereof, momethasone, tipredane, RPR 106541 and/or a β2-agonist such as terbutaline, salbutamol, formoterol, salmeterol, TA 2005, pircumarol or a pharmaceutically acceptable salt thereof; and/or a prophylactic agent such as sodium chromoglycate or nedocromil sodium (col.1, lines 37-54 and claims 4-6 of prior art); the carrier includes e.g., lactose, glucose, raffinose … starch (col. and claims 9-10 of prior art); the active substance and carrier substance are substantially uniformly distributed in the dry powder composition through remicronization step and does not disturb the crystallinity of the fine particles (col.1, line 64- col. 2, line 2, the Examples and claim 1 of prior art). The powder has a bulk density of 0.28 to 0.38 g/ml (abstract) which overlaps the instant range of between about 0.05g/cm3 and 0.30 g/cm3 (instant claim 35).
Weickert discloses pulmonary delivery of polyene antifungal agents, but which typically provides a uniform distribution of formulation components in the resulting, spray-dried particles (meaning that each of the particles in the final spray-dried formulation possesses substantially the same chemical composition and distribution of components within the particle) ([0088]). Therefore, since the spray-dried formulation possesses substantially the same chemical composition and distribution of components, it would be obvious to provide uniform drug loading among the particles as taught/suggested by Weickert.
It would have been obvious to modify the teachings of Gordon with homogenous distribution of component in the dry powder composition of Trofast and uniform loading due to same chemical composition and distribution of Weickert in order to enhance safety and performance of the dry powder.
It would have been obvious to modify the teachings of Gordon with bulk density of Trofast because both references are directed to providing free-flowing dry powder which is administered via inhaler for e.g., delivery for treating respiratory disorder, and require the similar ingredients of steroid, saccharides etc. and they are in analogous art; and accordingly, low bulk density of Trofast would enhance the properties of the dry powder composition (e.g., good dispersion and manageable handling).
In light of the foregoing, instant claims 35, 38 and 40 are obvious over Gordon in view of Trofast and Weickert.
Claims 37 and 39 are rejected under 35 USC 103 as being obvious over Gordon et al. (US2002/0132011A1) in view of Trofast (US6,287,540B1) and Weickert et al. (US2002/0177562A1) and further in view of Whitfield et al. (US2010/0316724A1).
However, Gordon/Trofast/Weickert do not expressly teach hydroxypropylmethylcellulose (HPMC) or methylcellulose (MC) of instant claim 37; and distearoylphosphatidylcholine (DSPC) of instant claim 39. The deficiencies are cured by Whitfield.
Whitfield discloses microparticles in the form of dry powder ([0029]) having a moisture content of less than about 5% ([0151]); the microparticles contain cannabinoid, nicotine, etc. ([0089]); buffer such as citrate ([0146]), carriers, excipients or bulking agent ([0055]) such as mannitol or trehalose ([0075]), raffinose ([0106]), etc.; and amino acid such as leucine, phenylalanine, tryptophan, etc. ([0074], [0089], and [0225]); the microparticles contain polysaccharide such as cellulose (e.g., methyl cellulose (MC) and hydroxypropymethyl cellulose (HPMC))([0110] and [0145]) (instant claim 37); and surfactants ([0146] and [0203]) including lecithin or phospholipid (e.g., DPPC) ([0237]), fatty acids, phosphatidylcholine, DPPC, etc. ([0227]). Although Whitfield does not expressly teach DSPC (=diasteroylphosphatidylcholine) of instant claim 39, this prior art teaches fatty acid, phosphatidylcholine, dipalmitoylphosphatidylcholine, and therefore, it would be obvious to modify the surfactants of Whitfield with DSPC, and such replacement would have yielded no more than the predictable results of surfactant, absent evidence to the contrary is given (instant claim 39); the microparticles have a bulk density of no more than about 0.2g/cm3 ([0041]).
It would have been obvious to modify the teachings of Gordon/Trofast/Weickert with cellulose additives of Whitfield in order to enhance the properties of the dry powder composition.
Accordingly, instant claims 37 and 39 are obvious over Gordon/Trofast/Weickert in view of Whitfield.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that 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 was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments have been fully considered, but are moot in view of new references of Trofast and Weickert.
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 21-35 and 37-40 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,328,216B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because US ‘216 is directed to a method of manufacturing a flowable and dispersible powder and the claimed invention is directed to a flowable dry powder. However, both claim sets require lipophilic substance (=insoluble or slightly insoluble substance), identical MMAD, FPF and DE, tap density, bulk density, moisture content, same one or more additives. Further, patent ‘216 disclosure has the same composition for use in the method. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘216 subject matter.
Claims 21-35 and 37-40 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,833,118B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because US ‘118 is directed to a method of manufacturing a flowable and dispersible powder and the claimed invention is directed to a flowable dry powder. However, both claim sets require lipophilic substance (=insoluble or slightly insoluble substance), identical MMAD, FPF and DE, tap density, bulk density, moisture content, same one or more additives including surfactant DSPC, amino acid. Further, patent ‘216 disclosure has the same composition for use in the method. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘118 subject matter.
Response to Arguments
For the reasons set forth above, this double patenting rejections have maintained as Applicants have deferred to rebut the rejections under Rejection, Obviousness Type Double Patenting.
Conclusion
All claims examined are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/Primary Examiner, Art Unit 1613
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