DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s election without traverse of Group II in the reply filed on 8/29/2025 is acknowledged.
Claims 1-7, 9-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/29/2025.
INFORMATION DISCLOSURE STATEMENT
2. Information Disclosure Statements filed 4/28/2023 is acknowledged.
Claim Rejections- 35 USC § 103
3. 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.
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Frey et al. (US 20140242067) in view of Wenig et al. (US Patent 4778810) and Eskelinen et al. “Caffeine as a protective factor in dementia and Alzheimer’s disease.”
Frey et al. (US 20140242067) (hereinafter Frey et al. disclose intranasal administration of the composition directly to the nasal cavity to treat Alzheimer’s disease (abstract and para 0034). Frey et al. disclose stabilizing agents such as arginine, taurine and tryptophane and combinations thereof (para 0211). The composition is a dry powder (pulverulent) (para 0212).
Frey et al. does not teach caffeine. Wenig et al. (US Patent 4778810) (hereinafter Wenig et al.) disclose that it has been discovered that caffeine containing compositions can be successfully administered to mammals in novel nasal compositions at low dosage levels to elicit a systemic therapeutic response and to provide enhanced bioavailability, minimized variations in blood levels, more rapid onset of activity, ease of administration and reduced side effects (col. 1, lines 55-64).
Eskelinen et al. “Caffeine as a protective factor in dementia and Alzheimer’s disease” (hereinafter Eskelinen et al.) disclose caffeine and coffee drinking may be associated with a decresed risk of dementia and Alzheimer’s disease (abstract).
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 include caffeine in the compositions of Frey et al. for nasal delivery and treatment of Alzheimer’s. One would have been motivated to do so because caffeine may be associated with a decreased risk of Alzheimer’s disease.
4. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Frey et al. (US 20140242067) in view of Frank et al. “Effects of Anatomy and Particle Size on Nasal Sprays and Nebulizers”.
Frey et al. has been discussed supra and does not disclose that the composition has a mean particle size of more than 1 µm however, Frank et al. “Effects of Anatomy and Particle Size on Nasal Sprays and Nebulizers” (hereinafter Frank et al.). Larger particles greater than 10 µm have good penetration beyond the nasal valve an . 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 optimize the particle sizes in order to tailor how the particles are distributed in the nasal passage.
5. Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Frey et al. (US 20140242067) in view of Montagne “Drug-Taking Paraphernalia”.
Frey et al. has been discussed supra and does not disclose nasal applicator or snuff tube.
Montagne “Drug-Taking Paraphernalia” (hereinafter Montagne) disclose that snuff tubes are a form of administration and that the simplest is a straight, singular tube used for self-administration (see last paragraph on the left of page 163).. 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 delivery the nasal composition of Frey et al. with a snuff tube. One would have been motivated to do so because this is a form that is useful for self-administration.
6. Claim 17 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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