DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed 12/16/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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) 1-2, 4-11, 16, 66-68, 81 and 84-85 are rejected under 35 U.S.C. 103 as being unpatentable over Eagle et al (US 2019/0216834 A1), in view of Cynamon et al (US 2021/0346408A1).
Eagle taught methods for treating a pulmonary infection in a patient in need thereof, for example, a Mycobacterium abscessus [claim 34]. The method comprised administering to the lungs of the patient for an administration period, a composition comprising an aminoglycoside, or a pharmaceutically acceptable salt thereof, encapsulated in a plurality of liposomes (e.g., liposomal amikacin [0103]), wherein the lipid component of the plurality of liposomes consisted of one or more electrically neutral lipids (e.g., DPPC and cholesterol) [claims 2 and 12]; and an additional therapeutic agent against mycobacterial infections (e.g., imipenem) [0128]. The aminoglycoside was amikacin sulfate, and was administered once per day in a single dosing session [0050], wherein administering to the lungs of the patient comprised aerosolizing the composition to provide an aerosolized composition comprising a mixture of free aminoglycoside, or a pharmaceutically acceptable salt thereof, and liposomal complexed aminoglycoside, or a pharmaceutically acceptable salt thereof, and administering the aerosolized composition via a nebulizer to the lungs of the patient [claim 2].
Although Eagle generally taught additional therapeutic agents (e.g., imipenem) against Mycobacterium abscessus infections, Eagle was not specific the second active agent as newly recited in claim 1.
Cynamon taught, in addition to imipenem, biapenem, doripenem and tebipenem [0492] as active against Mycobacterium abscessus [0491]. 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 agents of Eagle (ipipenem) and Cynamon (imipenem, biapenem, doripenem and tebipenem), in order to form a composition with active agents, for the purpose of treating Mycobacterium abscessus infections, each as taught by Eagle [claim 34 and ¶ 0128] and Cynamon [0491-0492].
Eagle, in view of Cynamon, reads on claims 1-2, 4-7, 81 and 84-85.
Claim 8 is rendered prima facie obvious because Eagle taught that the liposome comprised unilamellar vesicles, multilamellar vesicles, or a mixture thereof [claim 13].
Claim 9 is rendered prima facie obvious because Eagle taught that the system provided therein comprised an about 8 mL liposomal amikacin composition [0089].
The instant claim 9 recites a volume from about 8 mL to about 10 mL.
Eagle taught a volume of about 8 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 10 is rendered prima facie obvious because Eagle taught that the composition comprised from about 500 mg to about 600 mg amikacin [0103]. See also paragraph [0080] for additional ranges of the taught dosages, which encompass the claimed ranges.
The instant claim 10 recites from about 500 mg to about 650 mg amikacin.
Eagle taught from about 500 mg to about 600 mg amikacin. A prima facie case of obviousness exists because of overlap, as discussed above.
Claim 11 is rendered prima facie obvious because Eagle taught about 65 mg/mL liposomal amikacin, about 80 mg/mL liposomal amikacin [0081]; about 32 to about 35 mg/mL DPPC and about 16 to about 17 mg/mL cholesterol [claim 17].
The instant claim 11 recites about 65-80 mg/mL amikacin; about 25-35 mg/mL DPPC and about 10-20 mg/mL cholesterol.
Eagle taught about 65 mg/mL liposomal amikacin, about 80 mg/mL liposomal amikacin; about 32 to about 35 mg/mL DPPC and about 16 to about 17 mg/mL cholesterol. A prima facie case of obviousness exists because of overlap, as discussed above.
Claim 16 is rendered prima facie obvious because Eagle taught that additional therapeutic agents were administered orally, intravenously or via inhalation [0122].
Claims 66-68 are rendered prima facie obvious because Eagle taught that during the administration period, or subsequent to the administration period, the patient exhibited an NTM culture conversion to negative, wherein NTM sputum culture conversion was defined as three consecutive negative NTM sputum cultures [claim 69; abstract].
Response to Arguments
Applicant’s arguments with respect to the instant claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim 82 is rejected under 35 U.S.C. 103 as being unpatentable over Eagle et al (US 2019/0216834 A1), in view of Cynamon et al (US 2021/0346408A1) and further in view of Hofmann et al (US 2022/0023282A1).
The 35 U.S.C. 103 rejection over Eagle, in view of Cynamon, was previously discussed.
Although Eagle generally taught additional therapeutic agents (e.g., imipenem) against Mycobacterium abscessus infections, Eagle was not specific the second active agent as newly recited in claim 82.
Hofman taught bedaquiline [abstract and title] as active against Mycobacterium abscessus [claim 115]. In the instant case, it is prima facie obvious to combine the active agents of Eagle (ipipenem) and Hofmann (bedaquiline), in order to form a composition with active agents, for the purpose of treating Mycobacterium abscessus infections, each as taught by Eagle [claim 34 and ¶ 0128] and Hofmann [abstract, title, claim 115].
Response to Arguments
Applicant’s arguments with respect to the instant claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1-2, 4-11, 16, 66-68 and 81-86 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 8,679,532, in view of Cynamon et al (US 2021/0346408A1).
Claims 1-2, 4-11, 16, 66-68 and 81-86 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 9,566,234, in view of Cynamon et al (US 2021/0346408A1).
Claims 1-2, 4-11, 16, 66-68 and 81-86 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-50 of U.S. Patent No. 10,398,719, in view of Cynamon et al (US 2021/0346408A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims require administration of a second active agent, further limited to biapenem, bedaqualine, tetrandrine, tebipenem, doripenem or RV40, which is not recited by the issued claims.
Cynamon taught biapenem, doripenem and tebipenem as active against Mycobacterium abscessus.
It would be prima facie obvious to include, within the issued claims, biapenem, doripenem and tebipenem, as taught by Cynamon. The ordinarily skilled artisan would be motivated to form a composition with active agents, for the purpose of treating Mycobacterium abscessus infections, as taught by Cynamon.
Claims 1-2, 4-11, 16, 66-68 and 81-86 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 8,642,075, in view of Cynamon et al (US 2021/0346408A1).
Claims 1-2, 4-11, 16, 66-68 and 81-86 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 8,673,348, in view of Cynamon et al (US 2021/0346408A1).
Claims 1-2, 4-11, 16, 66-68 and 81-86 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 8,673,349, in of Cynamon et al (US 2021/0346408A1).
Claims 1-2, 4-11, 16, 66-68 and 81-86 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-60 of U.S. Patent No. 9,827,317, in view of Cynamon et al (US 2021/0346408A1).
Claims 1-2, 4-11, 16, 66-68 and 81-86 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9,895,385, in view of Cynamon et al (US 2021/0346408A1).
Claims 1-2, 4-11, 16, 66-68 and 81-86 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 9,402,845, in view of Cynamon et al (US 2021/0346408A1).
Claims 1-2, 4-11, 16, 66-68 and 81-86 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,751,355, in view of Cynamon et al (US 2021/0346408A1).
Claims 1-2, 4-11, 16, 66-68 and 81-86 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-46 of U.S. Patent No. 10,588,918, in view of Cynamon et al (US 2021/0346408A1).
Claims 1-2, 4-11, 16, 66-68 and 81-86 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,828,314, in view of Cynamon et al (US 2021/0346408A1).
Claims 1-2, 4-11, 16, 66-68 and 81-86 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,446,318, in view of Cynamon et al (US 2021/0346408A1).
Claims 1-2, 4-11, 16, 66-68 and 81-86 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,395,830, in view of Cynamon et al (US 2021/0346408A1).
Claims 1-2, 4-11, 16, 66-68 and 81-86 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12,168,022, in view of Cynamon et al (US 2021/0346408A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims require treatment of Mycobacterium abscessus, via administration of a second active agent, further limited to biapenem, bedaqualine, tetrandrine, tebipenem, doripenem or RV40, which is not recited by the issued claims.
Cynamon taught biapenem, doripenem and tebipenem as active against Mycobacterium abscessus.
It would be prima facie obvious to include, within the issued claims, biapenem, doripenem and tebipenem, as taught by Cynamon. The ordinarily skilled artisan would be motivated to form a composition with active agents, for the purpose of treating Mycobacterium abscessus infections, as taught by Cynamon.
Response to Arguments
Applicant’s arguments with respect to the instant claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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.
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612