DETAILED ACTION
1. Receipt is acknowledged of Applicant’s amendments and remarks filed 8/6/2025.
INFORMATION DISCLOSURE STATEMENT
2. Information Disclosure Statement submitted 5/27/2025.
WITHDRAWN REJECTIONS
3. Rejections not reiterated from previous Office Actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
NEW REJECTIONS
Claim Rejections- 35 USC § 103
4. 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.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 21-22, 25-26 and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over (JP 2006522785) in view of (JP2011510963), (WO 2006059152),(US Patent 8772309) and Joguparthi et al. (US 20180200202).
(JP 2006522785) disclose compositions comprising apomorphine and inhaler formulation (abstract). The composition is nonaqueous and comprises ethanol less than 50 % by weight. The ‘785 reference discloses according to one embodiment of the present invention, a solution for pMDI comprising apomorphine or a pharmaceutically acceptable salt thereof is surprisingly provided by intentionally adding water to the system. That is, a suitable pMDI solution comprises HFA134a (1,1,1,2-tetrafluoroethane) and / or HFA227 (1,1,1,2,3,3,3-heptafluoropropane) from about 50% to a propellant solution containing about 98% (w / w), about 2% to about 10% (w / w) water, and about 0% to about 47% (w / w) ethanol, apomorphine or pharmaceutically (last paragraph of page 10). It appears to be obtained by adding an acceptable salt thereof. Preferably, the water is provided in an amount of greater than 5% to about 10% (w / w). The ethanol is preferably provided in an amount of about 12% to about 40% (w / w). The 12 ml solution preferably contains about 170 mg of apomorphine hydrochloride in addition to HFA134a, water and / or ethanol. A 3M coated (DUPONT 3200 200) canister may be used as an inhaler canister. Pressurized meter dosage inhalers are disclosed with a valved outlet. The reference teaches that typically, in pMDI, the contents of the canister are pressurized using a propellant and the drug particles are sprayed from the outlet of the receptacle component and disclose HFA spray.
JP 2006522785 does not disclose degassed water however, Joguparthi et al. (US 20180200202) disclose that degassed water for injection may be used to minimize a level of dissolved oxygen to protect the solution during compounding and filling from dissolved oxygen (para 0061). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have the water present be degassed as disclosed in Jaquparthi et al. for the purpose of minimizing a level of dissolved oxygen to protect the solution during compounding and filling from dissolved oxygen.
JP 2006522785 does not disclose MMAD greater than 10 µm (page 5-para 7) however, (JP2011510963) disclose that if particles or droplets are intended to penetrate deeply into the lung, they should have an aerodynamic median particle size (MMAD) of less than 10 µm. Conversely, if the spray is for buccal or nasal delivery, the particles or droplets must have a MMAD significantly greater than 10 µm to prevent them from entering the lungs (page 2, 5th full paragraph).
RESONSE TO ARGUMENTS
5. Applicants’ arguments have been fully considered and are not persuasive for the reasons below.
Applicants arguments are directed to the amendment to degassed water which has been addressed in the rejection supra.
Applicant further argues that the JP ‘785 teaches away from particle sizes of greater than 10 µm.
In response, this argument is not found persuasive because the reference teaches that the drug in Uprima® tablets, where the drug is slowly absorbed into the buccal mucosa and onset of therapeutic effect is delayed due to the small portion of the drug swallowed, and the drug is present in plasma for a long period of time and further teach that a study conducted by Nastech Pharmaceutical Company Inc on intranasal delivery of apomorphine showed that more than 2 mg of apomorphine can be administered intranasally in the clinical environment without causing unacceptable side effects. Thus, nasal delivery is suitable as well. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). “A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994).
CONCLUSION
6. 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.
CORRESPONDENCE
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANAH AL-AWADI/Primary Examiner, Art Unit 1615