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 . Claims 89-106 filed February 22, 2023 are currently pending.
Election/Restrictions
Applicant’s election without traverse of Group (I), claims 89-97 in the reply filed on 09/16/2025 is acknowledged. Claims 98-106 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/16/2025.
Priority
Acknowledgement is made of the national stage entry of PCT/CA2021/051148 filed 08/19/2021, which claims priority to U.S. Provisional Application 63069881 filed 08/25/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/27/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 (i.e., changing from AIA to pre-AIA ) 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, 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) 89-93 and 96 are rejected under 35 U.S.C. 103 as being unpatentable over Thies (WO2011/127164 published 10/13/2011).
Thies (WO2011/127164 published 10/13/2011) teaches the method of treating pulmonary fibrosis and idiopathic pulmonary fibrosis comprising administering a therapeutically effective amount of a Wnt and TGF-Beta catenin signaling inhibitor (claims 1-6, 13-15, 17-18). Compound FT-2103-2 is taught as potent inhibitor of Wnt and TGF-Beta catenin signaling (page 45 lines 15-30, page 49 lines 15-30, Figure 45). As evidenced by Figure 45 of Thies and page 16/Formula (I) of the present specification, compound FT-2103-2 of Thies is art-recognized as the claimed fenretinide.
Thies teaches treating human patients with the pulmonary disorder (page 23 lines 25-30, claims 1-6). Regarding claims 92-93, oral administration, nasal and pulmonary administration of said Wnt and TGF-Beta catenin signaling inhibitor to the afflicted patient is taught, in doses of 0.01-50 mg/kg of body weight per day (page 58 line 20 to page 59 line 8). As evidenced by Reagan-Shaw (FASEBJ Vol. 22 pages 659-661 published 2007), the average weight of a human adult patient is 60 kg (Table 1). Accordingly, the dosage range of the Wnt and TGF-Beta catenin signaling inhibitor to treat the pulmonary fibrosis disorder taught by Thies ranges from 0.6 mg to 3000 mg per day, which overlaps with the range embraced within claim 93. Applicant is reminded of MPEP 2144.05 wherein 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claims 92 and 96, Thies also teaches nasal and pulmonary administration of said Wnt and TGF-Beta catenin signaling inhibitor to the afflicted patient is taught, in doses of 1-2 g/kg of body weight per day, which also overlaps with the therapeutically effective range embodied in the claims (page 59 line 5 to page 59 line 20).
Therefore, one of ordinary skill in the art prior to the time of the invention, knowing that administration of a therapeutically effective amount of a Wnt and TGF-Beta catenin signaling inhibitor is an efficacious strategy to treat pulmonary fibrosis and idiopathic pulmonary fibrosis in an afflicted human patient as taught by Thies, said skilled artisan would have found it prima facie obvious to select and administer the potent Wnt and TGF-Beta catenin signaling inhibitor FT-2103-2 of Thies to said pulmonary fibrosis patient with a reasonable expectation that administration of said potent Wnt and TGF-Beta catenin signaling inhibitor would have treated the afflicted patient.
Applicant is reminded that “[I]t is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985).” Applicant is also reminded of MPEP 2144.07 wherein “[T]he selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
In the instant case, fenretinide or FT-2103-2 is taught by Thies as 1 of 114 potent Wnt and TGF-Beta catenin signaling inhibitors efficacious for the treatment of pulmonary fibrosis (claims 1-6, 13-15, 17-18). Accordingly, said skilled artisan would have readily predicted that administration of the potent Wnt and TGF-Beta catenin signaling inhibitor FT-2103-2 to the afflicted patient would have treated pulmonary fibrosis in the patient.
Claim(s) 94-95 are rejected under 35 U.S.C. 103 as being unpatentable over Thies (WO2011/127164 published 10/13/2011) as applied to claims 89-93 and 96 above, in view of Betancourt (US2017/0189356 published 07/06/2017).
As discussed above, Thies renders obvious the administration of the art-recognized potent Wnt and TGF-Beta catenin signaling inhibitor fenretinide (FT-2103-2) to treat pulmonary fibrosis and idiopathic pulmonary fibrosis in a human subject as Thies teaches that fenretinide is one of 114 potent Wnt and TGF-Beta catenin signaling inhibitors effective to treat the pulmonary disorder in the afflicted patient (claims 1-6, 13-15, 17-18). Oral administration of said Wnt and TGF-Beta catenin signaling inhibitor is taught by Thies, in overlapping doses of 0.01-50 mg/kg of body weight per day (page 58 line 20 to page 59 line 8). As evidenced by Reagan-Shaw (FASEBJ Vol. 22 pages 659-661 published 2007), the average weight of a human adult patient is 60 kg (Table 1). Accordingly, the dosage range of the Wnt and TGF-Beta catenin signaling inhibitor to treat the pulmonary fibrosis disorder taught by Thies ranges from 0.6 mg to 3000 mg per day, which overlaps with the range embraced within claim 93. Applicant is reminded of MPEP 2144.05 wherein 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
The difference between the presently claimed methodology of Thies and that of the present claims is that Thies does not specifically teach wherein fenretinide is administered as an amorphous solid dispersion.
Betancourt (US2017/0189356 published 07/06/2017) teaches amorphous solid dispersions of fenretinide that are suitable for oral administration (abstract, [0007], claim 1). Betancourt teaches formulating said amorphous solid dispersion of fenretinide with 59.6 % povidone K30, the antioxidants BHT and BHT (Table 41, L215-01023). As evidenced by page 33 lines 15-25 of the present specification, a solid amorphous dispersion of fenretinide comprising 59.6 % povidone K30, the antioxidants BHT and BHT reads on the limitation of LAU-7b of claim 95.
Therefore, one of ordinary skill in the art prior to the time of the invention knowing that oral administration of the Wnt and TGF-Beta catenin signaling inhibitor fenretinide is efficacious at treating pulmonary fibrosis in a subject in need as taught by Thies, said skilled artisan would have readily predicted that oral administration of an amorphous solid dispersion of fenretinide, such as LAU-7b of Betancourt would have treated the fibrotic disease in the afflicted patient.
MPEP 2143 provides rationale for a conclusion of obviousness including (B): Simple substitution of one known element for another to obtain predictable results;
In the present case, considering oral administration of the Wnt and TGF-Beta catenin signaling inhibitor fenretinide was taught as therapeutically effective for treating pulmonary fibrosis in a subject in need as taught by Thies, said artisan would have readily predicted that substitution of one oral fenretinide formulation, for another, such as an amorphous solid dispersion of fenretinide of Betancourt, the resulting oral administration of fenretinide would have treated pulmonary fibrosis in the afflicted patient.
Claim(s) 97 is rejected under 35 U.S.C. 103 as being unpatentable over Thies (WO2011/127164 published 10/13/2011) as applied to claims 89-93 and 96 above, in view of Azuma (Am J. Respir Crit Care Med Vol. 171 pages 1040-1047 published 2005).
As discussed above, Thies renders obvious the administration of the art-recognized potent Wnt and TGF-Beta catenin signaling inhibitor fenretinide (FT-2103-2) to treat pulmonary fibrosis and idiopathic pulmonary fibrosis in a human subject as Thies teaches that fenretinide is one of 114 potent Wnt and TGF-Beta catenin signaling inhibitors effective to treat the pulmonary disorder in the afflicted patient (claims 1-6, 13-15, 17-18). Oral administration of said Wnt and TGF-Beta catenin signaling inhibitor is taught by Thies, in overlapping doses of 0.01-50 mg/kg of body weight per day (page 58 line 20 to page 59 line 8). As evidenced by Reagan-Shaw (FASEBJ Vol. 22 pages 659-661 published 2007), the average weight of a human adult patient is 60 kg (Table 1). Accordingly, the dosage range of the Wnt and TGF-Beta catenin signaling inhibitor to treat the pulmonary fibrosis disorder taught by Thies ranges from 0.6 mg to 3000 mg per day, which overlaps with the range embraced within claim 93. Applicant is reminded of MPEP 2144.05 wherein 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
The difference between the presently claimed methodology of Thies and that of the present claims is that Thies does not specifically teach wherein fenretinide is administered in combination with pirfenidone.
Azuma (Am J. Respir Crit Care Med Vol. 171 pages 1040-1047 published 2005) teaches treating idiopathic pulmonary fibrosis in a subject in need comprising administering a therapeutically effective amount of pirfenidone, wherein the pirfenidone regimen was efficacious at reducing acute exacerbations in the fibrosis patient (abstract, pages 1043, 1046, left col.)
Therefore, one of ordinary skill in the art prior to the time of the invention knowing that oral administration of the Wnt and TGF-Beta catenin signaling inhibitor fenretinide is efficacious at treating idiopathic pulmonary fibrosis in a subject in need as taught by Thies, said skilled artisan would have readily predicted that administration of fenretinide with pirfenidone of Azuma would have treated said fibrotic disorder in the afflicted patient.
Motivation to administer fenretinide and pirfenidone together flows logically from the very fact each agent or combination of agents was known in the prior art to have the same therapeutic utility of treating idiopathic pulmonary fibrosis in a subject in need and, in turn, raises the reasonable expectation of success, that when combined, a composition comprising fenretinide and pirfenidone would be efficacious at treating idiopathic pulmonary fibrosis in the afflicted patient. The instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that 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 (MPEP 2144.06).
Conclusion
In view of the rejections set forth above, no claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGE W KOSTURKO whose telephone number is (571)270-5903. The examiner can normally be reached M-F 9:00-5:30.
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/GEORGE W KOSTURKO/Examiner, Art Unit 1621