DETAILED ACTION
Status of Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-8 are pending and are included in the prosecution.
Claim Interpretation
Regarding claims 1-8, the claimed aqueous solution is drawn to product claims and therefore the intended use of the solution, “for the treatment of interstitial lung disease in a subject, wherein the treatment comprises nebulized administration from a nebulizer by inhalation to the subject” does not carry patentable weight over the teachings of the prior art. Claim 2 is drawn to the aqueous solution according to claim 1, which is drawn to a product claim, and therefore the intended use of the solution “wherein the nebulized administration delivers pirfenidone at a total pirfenidone output rate of between 0.1 mL/min and 1.0 mL/min, or less than or equal to 0.5 ml/min, or less than 0.7 ml/min” does not carry patentable weight over the teachings of the prior art. Claim 8 is drawn to an aqueous solution which depends from claim 7 which depends form claim 1, which is drawn to a product claim, and therefore the intended use of the solution “wherein the liquid nebulizer: (i) after administration of the inhaled dose, achieves lung deposition of at least 7% of the pirfenidone administered to the mammal; (ii) provides a Geometric Standard Deviation (GSD) of emitted droplet size distribution of the aqueous solution of about 1.0 pm to about 2.5 pm; (iii) provides droplets of the aqueous solution emitted with the high efficiency liquid with: a) a mass median aerodynamic diameter (MMAD) of about 1 pm to about 5 pm; and/or b) a volumetric mean diameter (VMD) of about 1 pm to about 5 pm; (iv) provides a fine particle fraction (FPF=% 5 pm) of droplets emitted from the liquid nebulizer of at least about 30%; (v) provides an output rate of at least 0.1 mL/min; and/or (vi) provides at least about 25% of the aqueous solution to a mammal” does not carry patentable weight over the teachings of the prior art.
Claim Rejections - 35 USC § 103
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.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Surber (US 20120192861 A1).
Regarding claims 1-8, Surber is drawn to formulations of pirfenidone (abstract and claims 1-26).
Surber discloses an aqueous solution for nebulized inhalation administration comprising: water; pirfenidone, or a pyridone analog compound, at a concentration from about 10 mg/mL to about 50 mg/mL; optionally one or more buffers to maintain the pH between about pH 4.0 to about pH 8.0; and one or more co-solvents. In some embodiments, the pH of the aqueous solution if from about pH 4.0 to about pH 8.0 [0005].
Surber discloses a pharmaceutical composition for pulmonary delivery, comprising a solution of pirfenidone or pyridone analog having a concentration greater than about 34 mcg/mL, having an osmolality greater than about 100 mOsmol/kg, and having a pH greater than about 4.0. In some embodiments, the pirfenidone or pyridone analog concentration is greater than about 1.72 mg/mL. In some embodiments, the pirfenidone or pyridone analog concentration is greater than about 86 mg/mL. In some embodiments, the pirfenidone or pyridone analog solution has a permeant ion concentration from about 30 mM to about 300 mM. In some embodiments, the permeant ion is chloride or bromide. In some embodiments, the pirfenidone or pyridone analog solution has a pH from about 4.0 to about 8.0. In some embodiments, the pirfenidone or pyridone analog solution has an osmolality from about 100 mOsmol/kg to about 1000 mOsmol/kg [0034]. Surber discloses sodium chloride [0006], and sodium citrate [0357].
Surber discloses the high efficiency liquid nebulizer (vi) delivers at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, or at least about 80% of the fill volume [0422].
Surber discloses the drug may be present at a concentration from about 34 mcg/mL to about 463 mg/mL [0446]. Surber discloses provides an output rate of at least 0.1 mL/min [0014]. Surber discloses citrate buffer at a concentration of from about 0 mM to about 50 mM [0386]. Surber disclose a pH of 5.5 [0065]. Surber discloses a vibrating mesh nebulizer (claim 15).
Surber discloses wherein the liquid nebulizer:
(i) achieves lung deposition of at least 7% of the pirfenidone or pyridone analog compound administered to the mammal;
(ii) provides a Geometric Standard Deviation (GSD) of emitted droplet size distribution of the aqueous solution of about 1.0 μm to about 2.5 μm;
(iii) provides: a) a mass median aerodynamic diameter (MMAD) of droplet size of the aqueous solution emitted with the high efficiency liquid nebulizer of about 1 μm to about 5 μm;
b) a volumetric mean diameter (VMD) of about 1 μm to about 5 μm; and/or
c) a mass median diameter (MMD) of about 1 μm to about 5 μm;
(iv) provides a fine particle fraction (FPF=%≦5 microns) of droplets emitted from the liquid nebulizer of at least about 30%;
(v) provides an output rate of at least 0.1 mL/min; and/or
(vi) provides at least about 25% of the aqueous solution to the mammal (claim 16).
Surber does not explicitly disclose each of the components of the composition in a single embodiment.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Surber, to arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Surber discloses the required ingredients and is drawn to aqueous solutions comprising pirfenidone (abstract and claims 1-26). Further, one having ordinary still in the art would reasonably expect success in combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
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 §§ 706.02(l)(1) -
706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,023,342 B2.
The instant claims and the claims of the ‘342 Patent both require pirfenidone; sodium citrate; sodium chloride; and wherein the pH of the solution is about 5 to about 6.
The instant claims differ from the claims of the ‘342 Patent because instant claim 1 requires pirfenidone at concentrations of from about 4.0 mg/ml to about 16.0 mg/ml.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have made the claimed composition because 4.0 mg/ml to about 16.0 mg/ml and 3.0 mg/mL to about 20 mg/mL are overlapping ranges of pirfenidone.
This is a nonstatutory double patenting rejection.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,028,966 B2.
The instant claims and the claims of the ‘966 Patent both require pirfenidone; sodium citrate; sodium chloride; and wherein the pH of the solution is about 5 to about 6.
The instant claims differ from the claims of the ‘966 Patent because instant claim 1 requires pirfenidone at a concentration from about 4.0 mg/ml to about 16.0 mg/ml.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have made the claimed composition because 4.0 mg/ml to about 16.0 mg/ml and 0.1 mg/mL to about 20 mg/mL are overlapping ranges of pirfenidone.
This is a nonstatutory double patenting rejection.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,610,536 B2.
The instant claims and the claims of the ‘536 Patent both require pirfenidone; sodium citrate; sodium chloride; and wherein the pH of the solution is about 5 to about 6.
The instant claims differ from the claims of the ‘536 Patent because instant claim 1 requires pirfenidone at a concentration from about 4.0 mg/ml to about 16.0 mg/ml.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have made the claimed composition because 4.0 mg/ml to about 16.0 mg/ml and 0.1 mg/mL to about 20 mg/mL are overlapping ranges of pirfenidone.
This is a nonstatutory double patenting rejection.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,071,741B2.
The instant claims and the claims of the ‘741 Patent both require pirfenidone; sodium citrate; sodium chloride; and wherein the pH of the solution is about 5 to about 6.
The instant claims differ from the claims of the ‘741 Patent because instant claim 1 requires pirfenidone at a concentration from about 4.0 mg/ml to about 16.0 mg/ml.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have made the claimed composition because 3.0 mg/ml to about 16.0 mg/ml and 0.1 mg/mL to about 20 mg/mL are overlapping ranges of pirfenidone.
This is a nonstatutory double patenting rejection.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9,770,443 B2.
The instant claims and the claims of the ‘443 Patent both require pirfenidone; sodium citrate; sodium chloride; and wherein the pH of the solution is about 5 to about 6.
The instant claims differ from the claims of the ‘443 Patent because instant claim 1 requires pirfenidone at a concentration from about 4.0 mg/ml to about 16.0 mg/ml.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have made the claimed composition because 4.0 mg/ml to about 16.0 mg/ml and 0.1 mg/mL to about 20 mg/mL are overlapping ranges of pirfenidone.
This is a nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615