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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 fails to further limit the subject matter of claim 1 because the claim recited the amount of amino acid that is out of range of the amount recited in claim 1.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6, 9, 10, 12 and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Williams US 20130298921 A1.
This rejection has been withdrawn in view of the Amendment filed on 06/19/2026.
Claim Rejections - 35 USC § 103
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.
Claims 21-30 are rejected under 35 U.S.C. 103 as being unpatentable over Zuber et al. WO 2018002756 A1, in view of Levin et al. (J Psychopharmacol 2014) and Williams US 20130298921 A1.
Zuber teaches a free flowing inhalable dry powder comprises nicotine, a sugar and an amino acid. The dry powder has particle with a diameter size in a range from about 0.5 to about 10 µm, or from about 0.5 to about 5 µm measure as mass medium aerodynamic diameter. The powder comprises about 25 wt% or less nicotine or from about 5 to about 15 wt% nicotine. This disclosure relates to particles comprising nicotine, a sugar, and an amino acid. Particles may be formed having a specific particle size distribution. In illustrative examples, about 90%, or about 95%, or about 98% of the particles have a size of about 5 µm or less. In many of these examples, about 10% of the particles have a size of about 820 nanometers or less. The particles may have a mass median aerodynamic diameter in a range from about 1 to about 4 µm. Advantageously, the nicotine particles and powder formulation described herein provide for a homogenous and stable particle size sufficient to deliver nicotine to the lungs of a consumer at inhalation or air flow rates that are within conventional smoking regime inhalation or air flow rates. The nicotine particles and powder formulation described herein allows these particles to be formed by spray drying to achieve a specific and controlled particle size distribution while minimizing agglomeration or adherence to surfaces such as processing equipment surfaces. See page 1. The particle may include an amino acid or peptide (preferably formed of three or less amino acids). The amino acid or peptide may reduce adhesion forces of the particles forming the composition and mitigate or prevent agglomeration of the particles forming the composition. The particles forming the composition described herein thus may be a free flowing material and possess a stable relative particle size distribution during processing, transport and storage. The amino acid may be a single amino acid or molecule containing two or more amino acids such as a peptide. Useful amino acids may include leucine, alanine, valine, isoleucine, methionine, phenylalanine, tyrosine, tryptophan, or a combination thereof. One preferred amino acid is leucine or a leucine isomer such as, L-leucine. The particle may include a sugar. Sugar refers to simple sugars, monosaccharides, disaccharides, and polysaccharides. Without limitation, examples of suitable sugars are lactose, sucrose, raffinose, trehalose, fructose, dextrose, glucose, maltose, mannitol, or combinations thereof. Preferred sugars include trehalose or mannitol. See page 4. Nicotine present in an amount ranging from 0.5-20%, sugar in an amount ranging from 60-95%, and amino acid in an amount ranging from 1-10% is found in page 5.
The only thing missing from the teaching of Zuber is anatabine compound.
Levin teaches while nicotine is the primary alkaloid found in tobacco, it is not the only nicotinic acetylcholine receptor agonist present. Among alkaloid compounds similar to nicotine, anatabine is found to have similar structure to nicotine yet present more advantageous result over nicotine. See page 2.
Similar to the suggestion in the Levin reference, Williams teaches an inhalable composition comprising at least about 25 wt. % anatabine based on the total alkaloid weight. In some examples, anatabine is the sole alkaloid present in the composition, e.g., anatabine comprises 100 wt. % of the total alkaloid weight. In other examples, up to about 75 wt. % of one or more other alkaloids, such as nicotine, nornicotine, and/or anabasine, may be present in addition to anatabine. For example, anatabine and nicotine may be combined in a weight ratio (anatabine-to-nicotine) of about 50:1 to about 1:3, or from about 25:1 to about 1:2, from about 10:1 to about 3:2, or from about 5:1 to about 1:1. See paragraph 0017.
As such, it would have been prima facie obvious to one of ordinary skill in the art to, by routine experimentation optimize the teaching in Zuber in view of the teaching in the Levin and Williams with the expectation to obtain the claimed invention. This is because Zuber teaches an inhalable composition that comprises exactly every component of the present claimed invention except for anatabine. While Zuber teaches nicotine instead of anatabine, Williams teaches an inhalable composition that comprises nicotine and anatabine, thus provides the motivation to combine nicotine and anatabine to obtain the claimed invention. Further in view of the teaching in Williams, Levin suggested anatabine which is a known alkaloid compound that has similar structure to nicotine, yet providing a more advantageous and unexpected result over nicotine compound. Therefore, one of ordinary skill in the art would have been motivated to include anatabine in the inhalable composition taught in Zuber in view of the teaching of Levin and Williams with the expectation to obtain an inhalable powder comprising anatabine useful in pharmaceutical art.
Response to Arguments
Applicant's arguments filed 06/19/2026 have been fully considered but they are not persuasive.
Applicant argues that the claims have been amended to recite a transitional phrase “consisting essentially of” and a weight amount of anatabine of less than 17%.
Applicant’s arguments however are not persuasive over newly filed claims 21-30, which recited a “comprising of” transition phrase. Further, Applicant’s attention is called to the teaching in Zuber, which teaches the mount of active agent can be between about 5% and about 15 wt%. See Abstract and Page 1 and Claims. Accordingly, Zuber teaches the amount of active agent that falls within the claimed range is known in the art.
Thus, for at least the above reasons, the 103 rejection over Zuber in view of Levin and Williams is maintained.
Claims Allowable
Claims 1, 3, 4, 6, 8, 13, 16, 17 and 20 are allowed.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615
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