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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 18, 2026 has been entered. Upon further review of the claims as “originally filed”, as well as “as amended” currently, the following rejections are hereby being presented:
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 1-18 and 20-25 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, consequently, those claims that depend therefrom), the phrase “a filler comprising a cellulose material or cellulose derivative in an amount of about 10% to about 75% by weight” is ambiguous. It is unclear whether the “10% to 75% by weight” parameter refers to the concentration of the cellulose material/derivative within the filler composition itself or to the total weight of the overall oral product. For example, if the filler contains additional non-cellulosic components, these two interpretations produce very different structural composition ranges which render the claim scope unclear.
Also, regarding independent claim 1, the limitations requiring the product to “release about 50% or less by weight of the active ingredient within about 5 minutes of insertion of the oral product unto the oral cavity of a consumer” relies on many variables. For example, release rates inside a human oral cavity depend on any number of conditions (e.g., saliva, sucking habits, placement in the mouth, temperature, etc.). So, because the instant specification does not appear to define a standardized dissolution method that directly correlates to this “release” parameter, a person skilled in the art cannot evaluate if infringement occurs because a product might release 45% in one individual (infringing) and 55% in another individual (not infringing).
Further, in independent claim 1, it is noted that the limitation “wherein the active ingredient is bound to at least a portion of the filler” does not specify the mechanism of binding (e.g. ionic bonding, hydrogen bonding, physical adsorption physical absorption, etc.). It appears that the degree of binding is what dictates the 5-minute release profile, so failing to specify the manner in which the active ingredient is “bound” seems to render the term unclear.
Lastly, the Examiner notes that independent claim 1 employs the term “about” for separate times across three different parameters:
(1) “about 10% to about 75% by weight”
(2) “about 50% or less by weight”
(3) “about 5 minutes”
While the “about” modifier itself is not inherently indefinite, it does create ambiguity regarding the precise outer limit of the claim scope.
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, 5-8, 12-14, 18 and 20-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Axelsson et al (US. Pat. App. Pub. 2009/0293895.
Regarding independent claim 1, Axelsson et al discloses a snuff composition in the form of a bag or pouch for oral/buccal administration (see paras. [0001],[0011]-[0012]) (corresponding to the claimed “[a]n oral product”).
Axelsson et al further discloses nicotine (free base, salts, or complexes) as the active agent (see paras. [0001],[0009], [0036]) (corresponding to the claimed “active ingredient”).
Axelsson et al discloses microcrystalline cellulose (MCC) or cellulose derivatives as carriers/fillers, and teaches a nicotine-cellulose carrier present in concentrations ranges of “about 5% w/w to about 75% w/w” or “about 5% w/w to about to about 70% w/w”, as well as “from about 10 to about 100%” (see paras. [00012],[[0023],[0033],[0040]) (corresponding to the claimed “a filler comprising a cellulose material or cellulose derivative in an amount of about 10% to about 75% by weight”).
Axelsson et al discloses that nicotine is sorbed, adsorbed, or absorbed into/onto microcrystalline cellulose to form a “nicotine-cellulose carrier complex” or “adduct” (see paras. [0009],[[0029]) (corresponding to the claimed “wherein the active ingredient is bound to at least a portion of the filler”).
Axelsson et al discloses snuff bag compositions E-J that release 40% to 50% total nicotine over a 30-minute period (see paras. [0088]-[0092]). Inherently, the amount released at 5 minutes is strictly less than the total released at 30 minutes (i.e., <50%). Specifically, Axelsson et al’s Example 2 demonstrates that its MCC-nicotine pouch formulations release only 40-50% total nicotine after 30 minutes. Because cumulative dissolution would occur over time, a product releasing <50% at 30 minutes inherently releases far less than 50% at 5 minutes (corresponding to the claimed “wherein the oral product is configured to release about 50% or less by weight of the active ingredient within about 5 minutes of insertion of the oral product into the oral cavity of a consumer”).
Regarding claims 5-8, Axelsson et al discloses vacuum-drying the nicotine-MCC mixture to form a fine-grained (read: dry) powder for use in dry snuff pouches (see paras. [0087],[0090], Catch-Dry type). Such dried particulate compositions inherently possess a water content of about 30% or less, 20% or less, 10% or less, and within the range of 0.1 to 15% by weight.
Regarding claims 12-13, as stated above, Axelsson et al explicitly teaches that the active ingredient is nicotine, provided as a free base or salt (see paras. [0001],[0009], [0036]).
Regarding claim 14, Axelsson et al discloses that adding flavoring agents such as peppermint powder, menthol, and mint (see paras. [0013],[0051]-[0052], Example 1).
Regarding claim 15, Axelsson et al discloses using mint, peppermint, and menthol flavoring agents (see paras. [0051]-[0052], Example 1). Peppermint oil and menthol flavorings inherently contain organic compounds possessing the claimed bonds.
Regarding claim 18, Axelsson et al discloses that the MCC filler/carrier is in particulate form with a mean particle size of 15-250 microns (see paras. [0028],[0087]).
Regarding claim 20, as stated above, Axelsson et al explicitly discloses microcrystalline cellulose (MCC) as the filler component (see paras. [0012],[0022]-[0024],[0087]).
Regarding claim 21, Axelsson et al explicitly discloses tobacco-free white oral pouches because it makes no mention to a tobacco component and even states that its pouches are “without the carcinogenic risks derived from the tobacco” (see para. [0004]). As such, the Axelsson et al product inherently contains 0% tobacco material by weight (and thus no more than 10%).
Regarding claim 22, Axelsson et al discloses enclosing the particulate nicotine-cellulose mixture inside a permeable pouch/membrane (see paras. [0011]-[0012],[0090]).
Regarding claim 23, Axelsson et al explicitly discloses adding buffering salts (sodium carbonate, sodium hydrogen carbonate, sodium triphosphate), binders, zanthan (read: gum) and flavorants (read: humectants) to the product. And while it is clear that its product maybe be tobacco-free, it also states that its composition may include tobacco (paras. [0013],[0016],[0026],[0045]-[0048],Example 1).
Regarding independent claim 24, and dependent claim 25, Axelsson et al discloses a snuff composition in the form of a bag or pouch for oral/buccal administration (see paras. [0001],[0011]-[0012]) (corresponding to the claimed “[a]n oral product”).
Axelsson et al discloses that its nicotine compound is present in a concentration of at least about 0.1% w/w to about 40% w/w (see para. [0037]) (corresponding to the claimed “an active ingredient in an amount of about 0.1% to about 10% by weight”).
Axelsson et al further discloses nicotine (free base, salts, or complexes) as the active agent (see paras. [0001],[0009], [0036]) (corresponding to the claimed “active ingredient”).
Axelsson et al discloses microcrystalline cellulose (MCC) or cellulose derivatives as carriers/fillers and teaches a nicotine-cellulose carrier present in concentrations ranges of “about 5% w/w to about 75% w/w” or “about 5% w/w to about to about 70% w/w”, as well as “from about 10 to about 100%” (see paras. [00012],[[0023],[0033],[0040]) (corresponding to the claimed “a filler comprising a cellulose material or cellulose derivative in an amount of about 10% to about 75% by weight”; and the “wherein the filler is present in an amount of at least about 20% by weight” recitation of claim 25).
Axelsson et al discloses that nicotine is sorbed, adsorbed, or absorbed into/onto microcrystalline cellulose to form a “nicotine-cellulose carrier complex” or “adduct” (see paras. [0009],[[0029]) (corresponding to the claimed “wherein the active ingredient is bound to at least a portion of the filler”).
Axelsson et al discloses snuff bag compositions E-J that release 40% to 50% total nicotine over a 30-minute period (see paras. [0088]-[0092]). Inherently, the amount released at 5 minutes is strictly less than the total released at 30 minutes (i.e., <50%). Specifically, Axelsson et al’s Example 2 demonstrates that its MCC-nicotine pouch formulations release only 40-50% total nicotine after 30 minutes. Because cumulative dissolution would occur over time, a product releasing <50% at 30 minutes inherently releases far less than 50% at 5 minutes (corresponding to the claimed “wherein the oral product is configured to release about 50% or less by weight of the active ingredient within about 5 minutes of insertion of the oral product into the oral cavity of a consumer”).
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 2-4 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Axelsson et al (US. Pat. App. Pub. 2009/0293895).
Regarding claims 2-4, Axelsson et al discloses controlling active release profiles form MCC pouches, demonstrating total 30-minute releases of 40-50% (paras. [0088]-[0092], Example 2). While Axelsson et al does not explicitly quantify the exact percentage released at 30 seconds, or 5 minutes (e.g., 25%-50%, <25%, or <10% at 30 seconds), 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 fine tuned the active loading, particle size, or pouch permeability disclosed in Axelsson et al to achieve any desired incremental release rate. Selecting specific release aspects within known controlled-release conditions is a matter of routine experimentation.
Regarding claims 9-11, Axelsson et al discloses vacuum-dried nicotine-MCC powder formulations (as stated above). While it does not explicitly state the numerical “water activity” value, low water activity, in the claimed range, is an inherent property of dried particulate solids with low moisture content and salt as a chemical component which inherently prevents microorganism growth. To the extent that it is not inherent, adjusting moisture levels to control water activity to prevent microbial formation (i.e., mold) serving to enhance stability would have been obvious and standard tobacco formulation practice.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Axelsson et al (US. Pat. App. Pub. 2009/0293895) in view of Winterson et al (US. Pat. App. Pub. 2007/0095356).
Regarding claims 16-17, the specific claimed flavor compounds are not explicitly named in Axelsson et al; however, Winterson et al discloses a pouched smokeless product which includes flavorants, such as citral (aldehyde) (see para. [0061]). Hence, 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 chosen to include this flavorant into the oral product of Axelsson et al as such flavorant is already known in the tobacco art to provide flavor to smokeless oral products.
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
