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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 112 –
Indefiniteness and Broad to Narrow Limitations
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 1-25 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.
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, claims 1 and 25 recite the broad recitations “Forced Vital Capacity and Forced Expiratory Volume”, and the claims also recite “(FVC) and (FEV1)” which are the narrower statements of the range/limitation.
In the present instance, claim 14 recites the broad recitations “mass median aerodynamic diameter, geometric standard deviation and fine particle fraction”, and the claims also recite “(MMAD), (GSD) and (FPF; particle diameter less than 5 microns)” which are the narrower statements 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 Applicant is encouraged to remove the parentheses from the claims, at each instance of occurrence.
Claim Rejections - 35 USC § 103 - Obviousness
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.
Claim(s) 1-10 and 12-25 are rejected under 35 U.S.C. 103 as being unpatentable over Elliott et al (US 2013/0028942 A1), in view of Surber et al (US 2015/0044288 A1).
Elliott taught a formulation comprising a first and a second solution. The first solution comprised an active agent or a salt thereof (e.g., a nitrite compound dissolved in aqueous solution), and a buffer (e.g., phosphate, Tris); the second solution comprised an excipient aqueous solution (e.g., permeant ion solution). The solutions were provided in sterile solvents, separately, in air-tight containers (e.g., vial), and were admixed prior to administration. The admixture was contained in the reservoir [0241] of a nebulizer, to obtain, upon activation [0266], an aerosol formulation [0046, 0063, 0074-0075, 0153]. The permeant ion concentration was from about 30 mM to about 300 mM [abstract, 0042, 0060, 0062, 0115, 0155, 0158, 0163, 0224-0225, 0259, 0265, 0279-0280, 0283, 0391].
Additionally, ethanol, lactose and propylene glycol (e.g., reads on osmolality adjusting agents) were taught as optionally included within the solution comprising the active agent [0174, 0225, 0258, 0325]. The concentration of the solution containing the active was at least 1 mg/mL [0071]. Elliott was drawn, generally, to the treatment of pulmonary hypertension [0086, 0093, 0117-0119] (e.g., lung administration, taught at [0091]; reads on delivery by inhalation). The formulations were stable [0228].
Although Elliott taught active agents for the treatment of pulmonary hypertension, Elliott was silent a nintedanib salt; FEV, as recited in claim 1.
Surber taught [abstract] formulations of tyrosine kinase inhibitor compounds [title], said compounds comprising nintedanib or a salt thereof [0377], dissolved, in a container, in a sterile liquid solution [0053, 0114-0115, 0433, 0448]. The concentration of the tyrosine kinase inhibitor or salt thereof (e.g., nintedanib) was from about 0.1 mg/mL to about 100 mg/mL [0006]. The counterion of the salt was chloride [0305]; and, further included within the formulation was a buffer (e.g., phosphate, Tris) [0307, 0493]. The formulations were stable [0092]. Surber was broadly drawn to pulmonary diseases [0107], including pulmonary hypertension [claim 18, 0021, 0057], where a therapeutic effect was defined as a patient-reported statistically significant reduction in FEV1 and/or a slowed or halted progression in the same [0356].
Since Elliott taught active agents for the treatment of pulmonary hypertension, it would have been prima facie obvious to one of ordinary skill in the art to include a nintedanib salt within the teachings of Elliott, as taught by Surber. Generally, it is prima facie obvious to combine two compositions, each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea for combining them flows logically from there having been individually taught in the prior art. See MPEP 2144.06. In the instant case, it is prima facie obvious to combine the active agents of Elliott (e.g., nitrite salt) and Surber (e.g., nintedanib salt), in order to obtain a formulation comprising active agents for the treatment of pulmonary hypertension, each as taught by Elliott [0086, 0093, 0117-0119] and Surber [claim 18, 0021, 0057].
It would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Elliot, a patient-reported statistically significant reduction in FEV1 and/or a slowed or halted progression in the same, as taught by Surber. The ordinarily skilled artisan would have been motivated to have a therapeutic effect, in the treatment of pulmonary hypertension, as taught by Elliott.
Elliott, in view of Surber, reads on claims 1-2, 4, 7 and 16-22.
The instant claim 3 recites an active agent concentration between 0.005 mg/mL and less than 1.5 mg/mL.
Elliott taught that the concentration of the solution containing the active was at least 1 mg/mL. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. MPEP 2144.05 A.
Claim 5 is rendered prima facie obvious because Elliott taught a buffer concentration (e.g., sodium phosphate) of from about 0.1 mM to about 5 mM [0060, 0161-0162]. Fumarate, malate and maleate buffers were not required.
The instant claim 5 recites a buffer concentration between 0.01 mM and 1000 mM. Elliott taught a buffer concentration from about 0.1 mM to about 5 mM. A prima facie case of obviousness exists because of overlap, as discussed above.
Claims 6 and 10 are rendered prima facie obvious because Elliott taught chloride and bromide [0155, 0158]; Surber taught calcium and magnesium chloride; sodium and magnesium bromide [0021, 0040-41, 0393].
The instant claims 8-9 and 13 recite a permeant ion concentration between 30 mM to 1500 mM in the second solution; between 30 mM and 150 mM in the admixture; and, between 0.1 % and 99 % in either of the first and the second container or both and between 0.1 % and 20 % in the admixture; pH between 3.0 and 7.0; osmolality between 50 mOsmo/kg and 600 mOsmo/kg.
Elliott taught that the permeant ion concentration was from about 30 mM to about 300 mM [previously discussed]; about 75 % to about 96 % ethanol [0325]. Elliott further taught a resulting pH following formulation or admixture, of from about 4.7 to about 6.5, and having an osmolality of from about 100 to about 3600 mOsmo/kg [0044]. A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 12 is rendered prima facie obvious because Elliott taught, in an embodiment, the volume of Vial 1 (active ingredient solution) at 4 mL, and the volume of Vial 2 (excipient, e.g., permeant ion, solution) at 3 mL [0395]. In another embodiment, Elliott taught Vial 1 at 8 mL, and Vial 2 at 8 mL [0398].
The instant claim 12 recites a first to second solution volume ratio between 10:1 and 1:10.
Elliott taught a volume ratio of 4:3 or 8:8 (e.g., 1:1). A prima facie case of obviousness exists because of overlap, as discussed above.
Claim 14 is rendered prima facie obvious because Elliott taught a nebulizer allowing the formation of an aerosol; a MMAD between about 2 to about 5 microns; a GSD of less than or equal to about 2.5 microns; a FPF of less than 5 microns; a FPF of at least 30 %; an output rate of 0.55 mL/min, or 0.22 mL/min [0190, 0232, 0234, 0356, 0384].
The instant claim 14 recites a MMAD of 1-5 micron, GSD of 1.0 to 2.5, FPF less than 5 microns, FPF at least about 30 % and an output rate of at least 0.1 mL/min.
Elliott taught a MMAD between about 2 to about 5 microns; a GSD of less than or equal to about 2.5 microns; a FPF of less than 5 microns; a FPF of at least 30 %; an output rate of 0.55 mL/min, or 0.22 mL/min. A prima facie case of obviousness exists because of overlap, as discussed above.
Claim 15 is rendered prima facie obvious because Elliott taught mechanical ventilation with an in-line nebulizer [0153].
Claim 23 is rendered prima facie obvious because Elliott taught mixing instructions [0451].
Claim 24 is rendered prima facie obvious because Elliott taught, regarding liquid nebulizers, descriptions of techniques, protocols and characterization of aerosolized mist delivery [0235].
Claim 25 is rendered prima facie obvious because Surber taught a tyrosine kinase inhibitor, generally, administered in fixed combination with pirfenidone [0237]. The motivation to combine Surber with Elliott was previously discussed.
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Elliott et al (US 2013/0028942 A1), in view of Surber et al (US 2015/0044288 A1) and further in view of Kipp et al (US 2004/0266890).
Additionally, each of Elliott [0039] and Surber [0006] taught nebulized solutions.
However, the combined teachings of Elliott and Surber were silent a synthetic polymer filter substantially free of PVDF, as recited in claim 11.
Nevertheless, Kipp taught a nebulized solution [0013, 0055] pre-filtered through a nylon filter (e.g., nylon is inherently free of PVDF), in order to remove undissolved drug or particulate matter [0219].
Since the combined Elliott and Surber taught nebulized solutions, it would have been prima facie obvious to one of ordinary skill in the art to include nylon filters within the combined teachings of the prior art. The ordinarily skilled artisan would have been motivated to remove undissolved drug or particulate matter, as taught by Kipp [0013, 0055, 0219].
Nonstatutory Double Patenting
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 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,123,290.
Although the claims at issue are not identical, they are not patentably distinct from each other because the species (specially formulated compositions of inhaled nintedanib) recited in the claims of the issued patent falls within the genus (method to administer aerosol formulations of nintedanib) recited in the claims of the instant application, and thus read on the instant claims.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 12,090,225, in view of Elliott et al (US 2013/0028942 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. The instant claims require containing the admixture in the reservoir of a nebulizer, which is not required of the issued claims.
Elliott taught an admixture contained in a reservoir [0241] of a nebulizer, to obtain, upon activation [0266], an aerosol formulation.
It would have been prima facie obvious to one of ordinary skill in the art to include, within the issued claims, an admixture in a reservoir, as taught by Elliott. The ordinarily skilled artisan would have been motivated to activate the admixture in the nebulizer, to obtain an aerosol formulation, as taught by Elliott et al.
Conclusion
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/CELESTE A RONEY/ Primary Examiner, Art Unit 1612
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