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 .
Election/Restrictions
Claims 6 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 05/13/2025.
Response to Arguments
Applicant’s arguments filed 10/09/2025 traversing the rejection under 35 U.S.C. §103(a) based on Evans (US 2014/0069829 A1) in view of Fox (US 2002/0059939 A1) have been fully considered but are not persuasive.
Applicant contends that the cited references fail to teach or suggest the claimed “granular salt infused with nicotine,” asserting that Fox merely discloses nicotine in salt form and is silent regarding a granular structure. Applicant further argues that forming a specifically granular salt form would require special crystallization or processing steps not described in the cited art.
These arguments are not persuasive because Fox expressly teaches a granulate form of nicotine, which inherently corresponds to a granular physical structure. Specifically, Fox discloses that “the nicotine granulate comprises coated particles of powdered nicotine” and that “the nicotine granulate comprises particles of powdered nicotine encapsulated with coating materials such as sugar, starch, acacia, sodium alginate, carboxymethyl cellulose, and polyvinyl alcohol” (¶[0022]). The term “granulate” clearly describes a solid, particulate, or granular composition. Thus, Fox explicitly teaches a nicotine-containing granular composition, contrary to Applicant’s assertion.
Furthermore, Fox also teaches that the nicotine used in such formulations can be in the form of salts, including levo, dextro, and racemic nicotine salts (¶[0023]–[0024]). A person of ordinary skill in the art would have recognized that nicotine salts, like freebase nicotine, can be readily prepared and formulated as granular or particulate materials using the same encapsulation and coating methods described in Fox. Modifying the nicotine form in Evans to a granular nicotine salt as taught by Fox would have been a predictable and routine formulation variation, motivated by the express desire in Fox to improve the palatability, stability, and handling of particulate nicotine compositions. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).
Additionally, the recited “granular” characteristic does not impart any patentable structural or functional distinction over the prior art. In the absence of evidence demonstrating a critical property or unexpected result associated with the granular form, the claimed morphology is considered an obvious result of routine processing or inherent in the formation of solid salt compositions. See In re Best, 562 F.2d 1252 (CCPA 1977); In re Aller, 220 F.2d 454 (CCPA 1955).
Accordingly, Fox teaches or at least renders obvious the claimed “granular salt infused with nicotine,” and Applicant’s arguments do not overcome the prima facie case of obviousness. The rejection under 35 U.S.C. §103(a) is therefore maintained.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1, 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Evans (US 2014/0069829), and further in view of Fox (US 2002/0059939).
Regarding claim 1 and 3, Evans teaches a nicotine pouch assembly (packaged product 300) for facilitating a plurality of nicotine packets to be positioned in a porous pouch that is insertable into a user's mouth, said assembly comprising:
a canister (collapsible container 100) being comprised of a fluid impermeable material;
a lid 310 being removably attachable to said canister for opening and closing said canister (fig. 3). Evans further teaches a label 420 that provides production identification and a sealing function applied to surround the collapsible container and a portion of the lid [0042] (fig. 4) reading on the limitation of “said lid having a top surface said lid having indicia being applied to said top surface, said indicia comprising an image of a logo”.
a plurality of nicotine packets 320 (tobacco extracts added to a packaged product can include nicotine [0008]) each of said plurality of nicotine packets being stored within said canister (Fig. 3),
each of said nicotine packets being filled with a non-plant material (a collapsible container provided herein can be used to package non-tobacco [0008])
Applicant is reminded that the limitation of “non-plant material” is being interpreted as a non-tobacco material; non-plant material in each of said nicotine packets being infused with nicotine (a non-tobacco product can include one or more tobacco extracts. In some cases, tobacco extracts added to a packaged product can include nicotine [0008]),
Regarding the limitation of “a selected one of nicotine packets being insertable into a user's mouth wherein said selected nicotine packet is configured to be exposed to the user's saliva when said selected nicotine packet is positioned in the user's mouth thereby facilitating said nicotine packet in the user's mouth to release said nicotine into the user's saliva”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, Evans teaches all the structural components of the claimed invention and is directed to smokeless product intended to be used in the mouth packaged in a pouch-like package [0003] thereby capable of performing the claimed intended use.
Evans teaches each of said nicotine packets is comprised of a fluid permeable material (The pouch provides a liquid-permeable container for holding a quantity of smokeless tobacco [0031]) wherein each of said plurality of nicotine packets is configured to facilitate the user's saliva to penetrate said nicotine packets (see above) and nicotine packets is infused with a chemical flavor [0030].
Evans is silent to the nicotine packets containing a granular salt infused with nicotine.
However, Fox discloses an oral nicotine delivery device wherein the nicotine granulate comprises coated particles of powdered nicotine…to enhance palatability [0022] and salt forms of nicotine [0023]. The nicotine solution further comprises a flavoring [0034].
Therefore it would have been obvious for one of ordinary skill in the art before the effective filling date of the claimed invention to have optimized the product of Evans to include the nicotine granulate and flavoring of Fox for benefit of an improved nicotine dissolution and delivery upon oral use.
Regarding claim 4, Evans in view of Fox does not specifies the dimensions of the nicotine packets.
However Evans discloses a canister containing a plurality of oral nicotine pouches (see rejection for claim 1) and Fox discloses nicotine granules made for oral use and designed to deliver nicotine and flavors, therefore it would have been obvious for one of ordinary skill in the art before the effective filling date of the claimed invention to select a packet dimensions to correspond to that of the claimed invention since such modification would involve only a mere change in size of the packets.
It has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed product and a product having the claimed relative dimensions would not perform differently than the prior art product, the claimed product was not patentably distinct from the prior art product (MPEP §2144.04 IV A).
Furthermore, no evidence is provided or apparent in Applicant’s-as-filed specification that the particular dimensional thresholds recited produce unexpected results, nor is any criticality associated with these values.
Regarding claim 5, Evans teaches a nicotine pouch assembly (packaged product 300) for facilitating a plurality of nicotine packets to be positioned in a porous pouch that is insertable into a user's mouth, said assembly comprising:
a canister (collapsible container 100) being comprised of a fluid impermeable material;
a lid 310 being removably attachable to said canister for opening and closing said canister (fig. 3). Evans further teaches a label 420 that provides production identification and a sealing function applied to surround the collapsible container and a portion of the lid [0042] (fig. 4) reading on the limitation of “said lid having a top surface said lid having indicia being applied to said top surface, said indicia comprising an image of a logo”.
a plurality of nicotine packets 320 (tobacco extracts added to a packaged product can include nicotine [0008]) each of said plurality of nicotine packets being stored within said canister (Fig. 3),
each of said nicotine packets being filled with a non-plant material (a collapsible container provided herein can be used to package non-tobacco [0008])
Applicant is reminded that the limitation of “non-plant material” is being interpreted as a non-tobacco material; non-plant material in each of said nicotine packets being infused with nicotine (a non-tobacco product can include one or more tobacco extracts. In some cases, tobacco extracts added to a packaged product can include nicotine [0008]),
Regarding the limitation of “a selected one of nicotine packets being insertable into a user's mouth wherein said selected nicotine packet is configured to be exposed to the user's saliva when said selected nicotine packet is positioned in the user's mouth thereby facilitating said nicotine packet in the user's mouth to release said nicotine into the user's saliva”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, Evans teaches all the structural components of the claimed invention and is directed to smokeless product intended to be used in the mouth packaged in a pouch-like package [0003] thereby capable of performing the claimed intended use.
Evans teaches each of said nicotine packets is comprised of a fluid permeable material (The pouch provides a liquid-permeable container for holding a quantity of smokeless tobacco [0031]) wherein each of said plurality of nicotine packets is configured to facilitate the user's saliva to penetrate said nicotine packets (see rejection for claim 1) and nicotine packets is infused with a chemical flavor [0030]. Evans is silent to the nicotine packets containing a granular salt infused with nicotine.
However Fox discloses an oral nicotine delivery device wherein the nicotine granulate comprises coated particles of powdered nicotine…to enhance palatability [0022]. The nicotine solution further comprises a flavoring [0034].
Therefore it would have been obvious for one of ordinary skill in the art before the effective filling date of the claimed invention to have optimized the product of Evans to include the nicotine granulate and flavoring of Fox for benefit of an improved nicotine dissolution and delivery upon oral use.
Evans in view of Fox does not specifies the dimensions of the nicotine packets.
However Evans discloses a canister containing a plurality of oral nicotine pouches (see rejection for claim 1) and Fox discloses nicotine granules made for oral use and designed to deliver nicotine and flavors, therefore it would have been obvious for one of ordinary skill in the art before the effective filling date of the claimed invention to select a packet dimensions to correspond to that of the claimed invention since such modification would involve only a mere change in size of the packets.
It has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed product and a product having the claimed relative dimensions would not perform differently than the prior art product, the claimed product was not patentably distinct from the prior art product (MPEP §2144.04 IV A).
Furthermore, no evidence is provided or apparent in Applicant’s-as-filed specification that the particular dimensional thresholds recited produce unexpected results, nor is any criticality associated with these values.
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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JENNIFER A KESSIE/Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747