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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 30, 2025 has been entered.
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.
Claims 1-4, 8, 11, 14 and 24-28 are 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.
Regarding independent claim 1 (and, therefore, those that depend therefrom), in the amendment filed on April 30, 2025, Applicant amended the claims to include the following claim limitation: “nicotine…calculated as a free base…”; however, it is not entirely clear what this recitation means as the instant disclosure does not appear to define “calculated as a free base”. It is presumed that this language is attempting to recite the potency of nicotine in the oral composition but the specification does not indicate how exactly the potency is calculated, hence, the metes and bounds of the claim with this newly added phrase is unclear. It appears that Applicant is endeavoring to recite that the total concentration of the nicotine is measured based on weight of a unprotonated or “free” nicotine molecule rather than the weight of a nicotine salt or a mixture of salt and base forms, but it is not clear how this is measured. For example, is there an equation that the calculation is based on? Clarification and, preferably, claim amendment is requested.
Also, regarding independent claim 1, the phrase “nicotine is bound to at least a portion of the filler composition” is unclear. A thorough reading of the instant specification reveals that there is no mention of what this “bound to” phrase means so, once again, the metes and bounds of the claim with this phrase in it is unclear. How exactly is the nicotine bound to at least a portion of the filler? Is it via absorption/adsorption? Is it via chemical bonding? Or is the nicotine merely combined with at least a portion of the filler? Clarification and, preferably, claim amendment is requested.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIONNE WALLS MAYES whose telephone number is (571)272-5836. The examiner can normally be reached Mondays and Thursdays, 8:00AM - 4:00PM (EST).
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/DIONNE W. MAYES/Primary Examiner, Art Unit 1747