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 .
Response to Arguments
Applicant’s arguments presented in the “Remarks” filed on April 24, 2026 with respect to Rejection under 35 USC 112(b) of claims of record have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the following prior art:
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.
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 1-4, 8, 11, 14, 24-28 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/110075 (hereinafter referred to as “Nielsen et al”) in view of Skjak-Braek et al (US. Pat. No. 5,144,016).
Regarding independent claim 1, Nielsen et al discloses an oral nicotine formulation free of tobacco comprising:
-Nicotine present in a concentration ranging from about 0.1% to about 10% by weight, calculated as a free base (Note: Nielsen et al states that “nicotine” refers to nicotine in any form, when referring to nicotine amounts, the amounts refer to the amount of pure (read: free base) nicotine. Nicotine can be provided anywhere from at least 0.5 mg - 4.0 mg/dose (100 mg tablet). See page 4, lines 17-22; page 11, line 13, and Table 6, for example).
-A filler (disintegrant) component, such as microcrystalline cellulose, wherein at least a portion of the nicotine is bound to at least a portion of the filler/disintegrant component (See page 11, lines 15-16).
-Alginates or crosslinked alginic acid (See page 23, line 10. Note that Nielsen et al discloses that there can be more than one disintegrant, i.e. states “combinations thereof”).
Nielsen et al fails to explicitly disclose that (1) the alginates are in the form of a gel; and (2) that the gel is formed of an alginate that is crosslinked with a crosslinking agent (specifically calcium ions). However, Skjak-Braek et al discloses, in its “Background” section, that alginate gels are known in a variety of industries, including the pharmaceutical industry. It explicitly teaches that water-soluble alginates (such as sodium alginate) are reacted/crosslinked with a crosslinking agent comprising calcium ions to form a contiguous, swellable gel matrix. (see col. 1, line 1 - col. 2, line 1). Both Nielsen et al and Skjak-Braek et al operate in the identical fireld of pharmaceutical delivery of compositions using polysaccharide binders. Crosslinking soluble alginates with calcium ions is the dominant, conventional method in the art for producing alginate gels. Substituting Nielsen et al’s general alginate/alginic acid disintegrant with Skjak-Braek et al calcium-crosslinked alginate gel represents nothing more than the simple substitution of one known, functionally equivalent gel matrix for another to achieve the predictable results of forming a cohesive, swellable oral delivery gel. with It would have been obvious to one having ordinary skill in the art as of the effective filing date of the claimed invention to modify the oral nicotine composition of Nielsen et al by selecting an alginate crosslinked with a calcium ion crosslinking agent in the form of a gel, in order to provide for a controlled release of the active ingredient (i.e., nicotine) in the oral composition wherein the nicotine remains inside the alginate gel structure until a slow diffusion controlled release occurs, when the gel is swelled in water (i.e., saliva) as taught in Skjak-Braek et al.
Regarding claim 2, crosslinked alginate gels only dissolve when exposed to strong calcium-chelating agents and, as such, normal saliva which the modified Nielsen et al composition would be exposed to would not be adequate to dissolve crosslinked calcium-alginate hydrogels. As such, this claim limitation has inherently been met by the modified Nielson et al product.
Regarding clam 3, Skjak-Braek et al discloses calcium ions as crosslinking agents (see col. 3, line 7).
Regarding claim 4, Skjak-Braek et al discloses calcium chloride as the cross-linking agent (salt) (see col. 3, line 8).
Regarding claim 8, Skjak-Braek et al discloses that its gel can be provided in the form of microparticles (read: ground form) (see col. 7, lines 37-39).
Regarding claim 11, Nielsen et al discloses that its oral nicotine formulation can be provided in a pouch (see page 8, lines 27-28).
Regarding claim 14, Nielsen discloses that its oral nicotine formulation may take the form of a liquid i.e. spray) and may contain from 0.1-60% by weight of water (see page 32, lines 19-21) - falling within the claimed range.
Regarding claim 24, as stated above the gel may be on the form of microparticles (read: ground form) and, further, Nielsen et al states that the pouch of its invention may be constructed of non-woven cellulose fabric see page 54, lines 14-20).
Regarding claim 25, Nielsen et al discloses that the nicotine of its invention can be selected from the group that includes all of the claimed nicotine forms - free base nicotine, a nicotine salt, a resin complex of nicotine, and combinations thereof (see page 11, lines 12-16).
Regarding claim 26, nicotine polacrilex is a form of nicotine that Nielsen et al envisions (see page 11, line 14).
Regarding claim 27, Nielsen et al discloses that its oral nicotine formulation may include a “pH regulating agent” which may be in the form of an acid (See page 25, line 30 - page 26, line 1).
Regarding claim 28, it would have been obvious to one having ordinary skill in the art as of the effective filing date of the claimed invention to have added benzoic acid to the modified Nielsen et al oral nicotine composition as it would serve to act as a pH regulator and lower the pH of the gel, thus converting harsh nicotine into a smoother salt form of nicotine, i.e. nicotine benzoate - which is already envisioned by Nielson et al (see page 12, lines 1-8).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael H Wilson can be reached at 571-270-3882. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DIONNE W. MAYES/Primary Examiner, Art Unit 1747
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