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 (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.
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, 26-30 and 128-132 are rejected under 35 U.S.C. 103 as being unpatentable over Boni et al (USP 7,544,369 B2), in view, each, of Burke et al (WO 2016/073462 A1) and of Veit et al (Sci Transl Med, 2014, 6(246)).
Boni taught [abstract] a method of treating cystic fibrosis (CF) patients comprising the pulmonary administration (e.g., reads on administered to an airway of a patient), of an effective amount, of a liposomal/complexed anti-infective, to the patient. The anti-infective was amphotericin B (AmB) [col 2, line 46], and the lipid component of the liposome was cholesterol [claims 1 and 5].
The “liposomal or lipid-complexed' antiinfective, or “liposomal/complexed antiinfective, or “Lip-antiinfective.” or “Lip-An' discussed therein was any form of antiinfective composition where at least about 1% by weight of the anti-infective was associated with the lipid either as part of a complex with the lipid, or as a liposome where the antibiotic was in the aqueous phase, or the hydrophobic bilayer phase, or at the interfacial headgroup region of the liposomal bilayer (e.g., reads on in a single pharmaceutical composition) [col 3, lines 8-15]. The delivery system was delivered by aerosol [col 4, lines 1-3].
Although Boni taught treating CF patients, as discussed, Boni was silent patients with F508∆ gene mutations, as recited in claim 1.
Burke disclosed methods for treating CF comprising administering, to a subject in need thereof, a therapeutically effective amount of AmB [abstract]. Burke showed that AmB restored normal apical surface liquid volume (e.g., an important marker for physiology in CF cell line epithelial monolayers) in CFTR-deficient human lung epithelia (e.g., cell lines derived from a patient with the most common F508∆/ F508∆ mutation) [Example 8].
Veit disclosed that most CF patients carry the ΔF508 mutation, which impairs CFTR folding, processing, function, and stability [abstract].
Since Boni generally taught treating CF patients with AmB, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Boni, patients with the F508∆/ F508∆ mutation. The ordinarily skilled artisan would have been motivated to treat the most common mutation of CF, as taught by the combination of Burke [abstract, Example 8] and Veit [abstract].
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 their 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 ingredients of Boni’s (AmB) and Burke’s compositions (AmB), in order to form a composition with active agents for the treatment of CF. The idea for combining them flows logically from their having been individually taught in the prior art, generally for the treatment of CF patients (Boni), and specifically for the treatment of F508∆/ F508∆ CF patients (Burke)
Boni, Burke and Veit read on claims 1, 26-28 and 128.
Regarding claims 29 and 129-132, Boni did not teach CF refractory to treatment with ivacaftor; however, Veit taught [abstract] that studies in ΔF508 CF patients indicated little clinical benefit of monotherapy with ivacaftor, whereas combination clinical trials show limited but significant improvements in lung function.
It would have been prima facie obvious to one of ordinary skill in the art to include, within the combined teachings of the art, CF refractory to treatment with ivacaftor, as taught by Veit. The ordinarily skilled artisan would have been motivated to study CF treatment, thereby optimizing and maximizing the clinical benefit of combination therapy, as taught by Veit at the abstract.
Claim 30 is rendered prima facie obvious because Boni taught antibiotics [col 2, line 6; col 3, line 13]. Therapeutically effective amounts were previously discussed (see Burke).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Boni et al (USP 7,544,369 B2), in view, each, of Burke et al (WO 2016/073462 A1) and of Veit et al (Sci Transl Med, 2014, 6(246)) and further in view of Adler-Moore et al (Medical Mycology, 2016, 54(3), 223-231).
The 35 U.S.C. 103 rejection over Boni, Burke and Veit was previously discussed.
Additionally, Boni taught water [col 14, line 40], amphotericin B (previously discussed) and liposomes comprising HSPC [col 4, line 47], cholesterol (previously discussed) and DSPG [col 4, line 64]. Boni taught administration for inhalation by aerosol (previously discussed) [col 4, lines 1-5].
Boni disclosed alpha-tocopherol as used to form liposomes, whereby the alpha-tocopherol reduced the toxicity of the enclosed agents [col 6, lines 47-56].
However, Boni did not specifically teach alpha-tocopherol. Furthermore, although Boni taught liposomal formation, Boni was silent sucrose and disodium succinate hexahydrate, as recited in claim 11.
Nevertheless, Adler-Moore taught liposomal formulations of amphotericin B [title and abstract], where AmBisome is a commercially available formulation comprising [Table 1] amphotericin B, sucrose, HSPC, DSPG, cholesterol, alpha-tocopherol and disodium succinate hexahydrate). AmBisome reduced toxicity, thereby minimizing the adverse effects of AmB on host tissues [page 224, 2nd and 3rd full paragraphs].
Since Boni taught liposomal formulations of amphotericin B, whereby liposomes with reduced toxicity of the enclosed agents were suggested, it would have been prima facie obvious to one of ordinary skill in the art to include AmBisome within the teachings of Boni. An ordinarily skilled artisan would have been motivated to include commercially available liposomal formulations of amphotericin B with reduced toxicity, thereby minimizing the adverse effects of AmB on host tissues, as taught by Adler-Moore [Adler-Moore page 224, 2nd and 3rd full paragraphs].
Claims 126-127 are rejected under 35 U.S.C. 103 as being unpatentable over Boni et al (USP 7,544,369 B2), in view, each, of Burke et al (WO 2016/073462 A1) and of Veit et al (Sci Transl Med, 2014, 6(246)) and further in view of de Amorim et al (University of Lisbon, 2013, Dissertation).
The 35 U.S.C. 103 rejection over Boni, Burke and Veit was previously described.
Although Boni was drawn to the treatment of cystic fibrosis patients [claim 2], Boni was silent patients having Q2X and/or S4X mutations, as recited in claims 126-127.
De Amorim taught the characterization of CFTR nonsense mutations, whereby characterization of the CFTR gene allows for therapeutic lines of research to treat patients carrying these mutations [title and page 60, penultimate paragraph]. As per de Amorim, Q2X and S4X are naturally occurring nonsense mutations of the CFTR gene of cystic fibrosis, which is the most common lethal autosomic recessive disorder in the Caucasian population [English abstract, at page 9].
Since Boni was drawn to treating CF patients, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Boni, patients with Q2X and/or S4X mutations. The ordinarily skilled artisan would have been motivated to treat patients carrying naturally occurring mutations of CF, which is the most common lethal autosomic recessive disorder in the Caucasian population, [de Amorim, pages 9 and 60].
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, 11, 26-30 and 126-130 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12090164.
Although the claims at issue are not identical, they are not patentably distinct from each other because the species (genotype-agnostic rescue of cystic fibrosis with small molecule bicarbonate channels) recited in the claims of the issued patent falls within the genus (methods of treating cystic fibrosis) recited in the claims of the instant application, and thus read on the instant claims.
Claims 1, 11, 26-30 and 126-130 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31-32, 38, 41-42 and 46-61 of copending Application No. 18/886,318.
Although the claims at issue are not identical, they are not patentably distinct from each other because species (genotype-agnostic rescue of cystic fibrosis with small molecule bicarbonate channels) recited in the copending claims falls within the genus (methods of treating cystic fibrosis) recited in the claims of the instant application, and thus read on the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612
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