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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/06/2026 has been entered.
Response to Arguments
Applicant's arguments filed 02/06/2026 have been fully considered but they are not persuasive for the reasons set forth below.
Applicant argues that Nielsen is limited to nicotine–ion exchange resin (polacrilex) systems and therefore fails to anticipate the presently claimed nicotine composite formulation, which explicitly excludes ion exchange resins and polacrilex. This argument is not persuasive.
Nielsen is not limited to embodiments employing ion exchange resins. Rather, Nielsen teaches nicotine complexed with polymers and/or cyclodextrins and incorporated into moistened nicotine pouch formulations. The presence of embodiments employing ion exchange resins does not negate anticipation where Nielsen also teaches nicotine/polymer and nicotine/cyclodextrin complexes that meet the limitations of claim 1.
Applicant further argues that the claimed use of supercritical CO₂ encapsulation yields a structurally distinct product not taught by Nielsen. However, claim 1 is directed to a composition, not a method of manufacture. The recitation of supercritical CO₂ encapsulation constitutes product-by-process language and does not impose a structural limitation absent a positively recited structural distinction. Claim 1 does not recite any structural feature, morphology, or measurable property that distinguishes the resulting nicotine complex from those taught by Nielsen. Accordingly, the recited process does not confer novelty on the claimed composition.
Applicant also argues that amended claim 1 requires a physical separation between nicotine and moisture such that the nicotine is permanently isolated from water and therefore distinguished from Nielsen. This argument is not persuasive. Claim 1 recites a mixture comprising an encapsulated hydrophobic nicotine powder and a separate water-entrapped powder complex, “wherein the nicotine in the encapsulated hydrophobic nicotine powder is isolated from contact with water.” However, the claim does not recite any positively defined structural feature that enforces a permanent or absolute physical separation between nicotine and moisture.
The claim does not require, for example, a continuous impermeable barrier, a defined coating thickness, a membrane, a layered configuration, or any other structural mechanism that would prevent water from contacting nicotine under all conditions.
Rather, the recited isolation from contact with water describes a functional condition or result, namely reduced or delayed exposure of nicotine to moisture by virtue of encapsulation or complexation. The term “separate” refers to the components of the mixture and does not require that the components remain spatially segregated after mixing. Under a broad but reasonable interpretation, the claim encompasses formulations in which nicotine is encapsulated or complexed in a manner that reduces direct exposure to moisture while still forming a moistened composition.
Nielsen teaches nicotine complexed with polymers and/or cyclodextrins that inherently limit direct contact between nicotine and moisture while being incorporated into moistened pouch formulations. Accordingly, Nielsen meets the claimed limitation of nicotine being isolated from contact with water as broadly claimed.
With respect to the negative limitations excluding ion exchange resins and polacrilex, Applicant’s arguments improperly rely on the exclusion of preferred embodiments disclosed in Nielsen. Anticipation requires only that a single embodiment of the reference meet the claim limitations. Nielsen discloses embodiments employing polymers and cyclodextrins other than polacrilex, and thus anticipates the claimed formulation even when ion exchange resin embodiments are excluded.
Applicant further argues that Nielsen teaches away from the claimed invention. However, Applicant’s argument improperly attempts to limit Nielsen to certain embodiments or preferences described therein. For purposes of anticipation, a reference need only disclose the claimed subject matter and is not limited to embodiments characterized as preferred, advantageous, or exemplary. As discussed above, Nielsen expressly teaches nicotine complexation with polymers and/or cyclodextrins in moistened nicotine formulations that meet the limitations of claim 1. Accordingly, Applicant’s characterization of Nielsen as teaching away does not overcome the rejection.
Applicant’s reliance on asserted functional advantages, including improved stability, organoleptic properties, and pH-independent release, is not persuasive. Such advantages are not recited as structural limitations in claim 1 and therefore do not distinguish the claimed composition from the disclosure of Nielsen for purposes of anticipation.
Accordingly, Nielsen teaches all the limitations of claim 1, and the rejection under 35 U.S.C. § 102(a)(1) is maintained.
Election/Restrictions
Claims 9-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/26/2025.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-8 and 21-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nielsen et al. (US 2022/0151292).
Regarding claim 1, Nielsen et al. (US 2022/0151292 A1) teaches a moistened nicotine powder composite (nicotine pouch composition; title) comprising a mixture of the following components.
Nielsen teaches an encapsulated hydrophobic nicotine powder mixture, as disclosed in powdered nicotine compositions outlined in Tables 9–21 (¶[0293]), comprising:
nicotine complexed with at least one polymer, such as block copolymers including poloxamers (¶[0256]),
at least one cyclodextrin, as disclosed among suitable nicotine-complexing additives (¶[0255]), and
a bulking agent, wherein the bulking agent is a water-insoluble fiber selected from wheat fibers and pea fibers (¶[0128]).
The limitation reciting that the nicotine is “encapsulated and complexed via a supercritical CO₂ process” constitutes product-by-process language. The supercritical CO₂ process is an extraction or processing method for nicotine and does not result in a nicotine composition that is structurally or functionally distinct from nicotine complexes produced by other methods. Claim 1 does not recite any structural feature distinguishing nicotine processed via supercritical CO₂ from nicotine processed by alternative techniques. Accordingly, recitation of “nicotine complexed via a supercritical CO₂ process” does not impart patentable weight to the claimed composition (see MPEP § 2113).
Nielsen further teaches a water-entrapped powder complex comprising:
a water-absorbing powder blend comprising microcrystalline cellulose, wherein nicotine is bound to cellulose materials such as microcrystalline cellulose (¶[0099]),
a gelling agent, such as sodium alginate (¶[0241]), and
an anti-caking agent, such as silicon dioxide acting as a glidant (¶[0305]).
Nielsen further teaches an aqueous solution comprising:
water, wherein the pouch composition comprises water in an amount of about 15–65% by weight of the composition, such as 15–60% by weight (¶[0207]),
a water-soluble sweetener, such as sucrose and other saccharide-containing sweeteners commonly used in oral pouch products (¶[0265]), and
a pH adjuster, such as acetic acid and other pH-regulating agents (¶[0258]).
The limitation reciting that the nicotine in the encapsulated hydrophobic nicotine powder is “isolated from contact with water” in the water-entrapped powder complex describes a functional condition or result, rather than a positively recited structural requirement. Claim 1 does not require a permanent physical barrier, membrane, coating thickness, layered configuration, or other structural mechanism that would prevent contact between nicotine and water under all conditions. Under a broad but reasonable interpretation, this limitation encompasses nicotine that is encapsulated or complexed in a manner that reduces direct exposure to moisture. Nielsen teaches nicotine complexation with polymers and/or cyclodextrins that inherently limit direct contact between nicotine and moisture while still forming a moistened composition suitable for oral use (¶¶[0255]–[0256], [0293]).
The limitations reciting that the nicotine composite formulation does not comprise an ion exchange resin and that the at least one polymer is not polacrilex exclude certain embodiments disclosed in Nielsen. However, Nielsen is not limited to ion-exchange resin embodiments and expressly teaches nicotine complexation with polymers and cyclodextrins other than polacrilex (¶¶[0255]–[0256]). Anticipation requires only that a single embodiment of the reference meet the claim limitations. Accordingly, Nielsen anticipates the claimed formulation even when embodiments employing ion-exchange resins are excluded.
Therefore, Nielsen teaches each and every limitation of claim 1, and claim 1 is rejected under 35 U.S.C. § 102(a)(1) as anticipated by Nielsen et al.
Regarding claim 2, Nielsen teaches wherein the encapsulated hydrophobic nicotine powder mixture further comprises at least one flavoring agent (Non-exhaustive examples of flavors suitable in embodiments of the present invention are coconut [0270]).
Regarding claim 3, Nielsen teaches wherein the encapsulated nicotine powder further comprises a lipophilic sweetener (Preferred high intensity sweeteners include, but are not limited to sucralose [0261]).
Regarding claim 4, Nielsen teaches wherein the aqueous solution further comprises at least one humectant [0171].
Regarding claim 5, Nielsen teaches wherein the aqueous solution further comprises at least one flavoring agent (the flavor may be liquid [0302]).
Regarding claim 6, Nielsen teaches wherein moisture content is from about 5% to about 65% (the pouch composition comprises water in an amount of 15-65 % by weight of the composition, such as 15-60 % by weight of the composition [0207]).
Regarding claim 7, the limitation reciting that the nicotine content exhibits at least 70% stability after accelerated storage at 40 °C and 75% relative humidity recites a functional property of the claimed composition rather than a structural limitation.
As established in the rejection of claim 1, Nielsen teaches a nicotine pouch composition that is identical or substantially identical to the claimed composition. Where an identical or substantially identical composition is taught, the recited property is presumed inherent absent evidence to the contrary (see MPEP § 2112(III)).
Accordingly, the stability limitation of claim 7 is inherent in the nicotine compositions taught by Nielsen, and claim 7 is rejected under 35 U.S.C. § 102(a)(1) as anticipated by Nielsen et al.
Regarding claim 8, Nielsen teaches further comprising a pouch, wherein the pouch is permeable for saliva (oral pouched nicotine product comprising a saliva - permeable pouch [0192]).
Regarding claim 21, Nielsen teaches that the nicotine pouch composition may include cyclodextrins, including α-cyclodextrin and β-cyclodextrin, as suitable inclusion agents or stabilizers (see ¶[0256]). Accordingly, Nielsen anticipates claim 21.
Regarding Claim 22, Nielsen expressly discloses poloxamer among the suitable polymers or additives used in the nicotine pouch compositions (see ¶[0256]).
Regarding claim 23, Nielsen discloses pouch compositions containing microcrystalline cellulose as a structural or bulking agent for forming the pouch matrix (see ¶[0099]).
Regarding claim 24, Nielsen discloses that water may be added as a separate component to the pouch composition, either fully or partially mixed into other components such as fibers (¶¶[0101]–[0105]).
Regarding claim 25, Nielsen discloses that the nicotine pouch composition may comprise flavors, including menthol, as a natural or synthetic flavoring agent or essential oil (see ¶¶[0268]–[0270]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER KESSIE whose telephone number is (571)272-7739. The examiner can normally be reached Monday - Thursday 7:00am - 5:00pm.
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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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/JENNIFER A KESSIE/Examiner, Art Unit 1747