DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Status of the Claims
Claims 1 and 4-17 are pending. Claims 13-16 are withdrawn. Claim 1 has been amended.
Response to Amendments
The Examiner acknowledges Applicant's response filed on 7/10/2025 containing amendments and remarks to the claims.
Response to Arguments
Applicant’s arguments, see pages 5-6 of Remarks filed 7/10/2025, with respect to the rejection of claims 1 under 35 U.S.C. 102(a)(2) have been fully considered and are persuasive. The Applicant has amended claim 1 to include limitations that were not previously presented and are not anticipated by Black. Therefore, the rejection has been withdrawn. However, upon further consideration, new grounds of rejection are made in view of newly found prior art Gee in combination with previously presented prior art Black.
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.
Claims 1, 4-12, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Black et al. (US 2022/0312825 A1) in view of Gee et al. (US 2011/0180087 A1).
Regarding claim 1, Black discloses a nicotine containing article (“oral pouch product 6800”, Figs. 22-23, ¶ 0330) for smokeless and oral usage (¶ 0326), comprising:
a wrapping material (“pouch wrapper 6820” which includes “outer web 6850”, Fig. 22, ¶ 0331); and
a nicotine containing product (“filling material 6910”, Fig. 23, ¶ 0330; “filling material 6910” includes “nicotine”, ¶ 0346), the nicotine containing product being arranged inside the wrapping material (“pouch wrapper 6820” with “outer web 6850” defines “inner cavity 6900” configured to carry “filling material 6910”, Fig. 23, ¶ 0330-0331),
wherein the wrapping material encloses the nicotine containing product from all sides and thereby forms the nicotine containing article in the shape of a pouch (“pouch wrapper 6820 can be sealed around one or more edges”, Fig. 22, ¶ 0330),
wherein the wrapping material is fluid permeable and thereby allows a fluid to pass through it (“outer web 6850 can be formed of a permeable material or a semi-permeable material, such that, for example, saliva, water, or both saliva and water can pass through the outer web 6850 and into the inner cavity 6900 defined by the pouch wrapper 6820”, ¶ 0331),
wherein at least a part of the wrapping material comprises a cooling agent which causes a cooling effect when using the nicotine containing article (“the outer web 6850 may be impregnated or coated with at least one flavorant, at least one cannabis material, at least one tobacco material, at least one binder, at least one sensate or chemesthesis agent, at least one functional ingredient, at least one salivation inducing ingredient, or any combination thereof”, ¶ 0335; “the at least one sensate or chemesthesis agent may include . . . WS-3 (N-Ethyl-p-menthane-3-carboxamide) . . . which may be selected so as to provide a cooling sensation”, ¶ 0339),
wherein the cooling agent is neutral in taste and/or odour (although Black does not expressly state that WS-3 (N-Ethyl-p-menthane-3-carboxamide) is neutral in taste and/or odour, WS-3 (N-Ethyl-p-menthane-3-carboxamide) is explicitly listed by Applicant as a compound which may be used for the cooling agent (claim 6 of the presently submitted Amendments) and, as such, the evidence of record indicates that WS-3 (N-Ethyl-p-menthane-3-carboxamide) is neutral in taste and/or odour; where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977); MPEP § 2112.01(I)).
Black also discloses a part of the wrapping material comprises a flavouring agent (“[t]he at least one flavorant may be . . . a triglyceride”, ¶ 0336).
With regards to the cooling agent being mixed with the flavouring agent before being applied to the part of the wrapping material, this limitation refers to the specific process by which the product is made. However, the patentability of a product does not depend on its method of production. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985); MPEP § 2113(I). In re Thorpe concerned a claimed product wherein the difference between the claimed and prior art products was the separate applications of metal oxide and carboxylic acid versus an application of a mixture of metal oxide and carboxylic acid. The court held that claimed product was unpatentable over the prior art because the end product is the same. Similarly, regardless of whether the cooling agent and flavouring agent of Black are applied consecutively or mixed together before application, the end product is the same.
With regards to the combination of the cooling agent and the flavouring agent simultaneously creating a flavoured taste experience with the cooling effect, as this “taste experience” is the result of the combination of a cooling agent and a flavouring agent on the wrapping material, and Black also discloses a cooling agent and a flavouring agent on the wrapping material, as discussed above, the nicotine article of Black will also have a “flavoured taste experience with cooling effect.” Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977); MPEP § 2112.01(I)).
Black discloses that the cooling agent exists as a coating on a surface of the wrapping material (“the outer web 6850 may be impregnated or coated”, ¶ 0335) but does not disclose that the cooling agents exists on the inner surface of the wrapping material without soaking into the wrapping material.
Gee, in the same field of endeavor, discloses that the wrapping material may comprise two distinct layers (“a pouch wrapper including an inner web and an outer web”, ¶ 0002) with the coating between the two layers (“the coating is between the inner web and the outer web”, ¶ 0002). Gee discloses a benefit to this configuration in that “[t]he inner web 18 reduces staining of the outer web 16 by reducing the opportunity for moisture from the inner botanical filling material 22 or its additives to reach the outer web 16 prior to use” (¶ 0034). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to form the wrapping material of Black to have both an inner web and an outer web with the cooling agent of Black between the two webs in order to obtain this benefit. In the resulting configuration, the cooling agent is arranged on an inner surface of the wrapping material (i.e., the inner surface of the outer web) such that the cooling agent exists on the inner surface of the wrapping material without soaking into the wrapping material.
Regarding claim 4, Black in view of Gee teaches the nicotine containing article according to claim 1, as stated above. Black further discloses wherein the maximum amount of cooling agent per square metre of wrapping material is more than 0.2 g/m2 (“The at least one sensate or chemesthesis agent may be coated on or impregnated in the outer web 6850 in an amount ranging from about 0.01 % by weight to about 5% by weight based on the weight of the oral pouch product 6800”, ¶ 0339; “oral pouch product 6800 may weigh about 0.25 gram (g) to about 2.0 grams” and “oral pouch product 6800 has a major dimension in the range of about 0.20 inch to about 2.0 inches . . . and a transverse dimension in the range of about 0.25 to about 1.5 inches”, ¶ 0328; selecting all maximum values for weight and length, the maximum amount of cooling agent per square metre of wrapping material is approximately 26 g/m2, which is more than 0.2 g/m2).
Regarding claim 5, Black in view of Gee teaches the nicotine containing article according to claim 1, as stated above. Black discloses wherein the cooling agent comprises at least one substance which provides the cooling effect (“the at least one sensate or chemesthesis agent may include . . . WS-3 (N-Ethyl-p-menthane-3-carboxamide) . . . which may be selected so as to provide a cooling sensation”, ¶ 0339).
Regarding claim 6, Black in view of Gee teaches the nicotine containing article according to claim 1, as stated above. Black discloses wherein the cooling agent comprises WS-3 (N-Ethyl-p-menthane-3-carboxamide) (“the at least one sensate or chemesthesis agent may include . . . WS-3 (N-Ethyl-p-menthane-3-carboxamide) . . . which may be selected so as to provide a cooling sensation”, ¶ 0339).
Regarding claim 7, Black in view of Gee teaches the nicotine containing article according to claim 1, as stated above. As discussed in the rejection of claim 1 above, Black discloses wherein the wrapping material and/or the nicotine containing product comprise the flavouring agent, which further comprises at least one flavouring component (“[t]he at least one flavorant may be . . . a triglyceride”, ¶ 0336).
Regarding claim 8, Black in view of Gee teaches the nicotine containing article according to claim 1, as stated above. Black further discloses wherein the cooling agent comprises nicotine (“the outer web 6850 may be impregnated or coated with at least one flavorant, at least one cannabis material, at least one tobacco material, at least one binder, at least one sensate or chemesthesis agent, at least one functional ingredient, at least one salivation inducing ingredient, or any combination thereof”, ¶ 0335; “The at least one cannabis or tobacco material may include, for example only, a ground cannabis or tobacco material, cannabis or tobacco plant fibers, and/or any extract thereof.”, ¶ 0337; “a tobacco extract, such as a tobacco-derived nicotine extract”, ¶ 0068) for intensifying the effect of the nicotine containing product (“The coating can provide an initial flavor burst upon placement of the oral pouch product 6800 in an oral cavity, while the inner filling material 6910 provides a later flavor release so as to prolong flavor release during placement in an adult consumer's mouth.”, ¶ 0335).
Regarding claim 9, Black in view of Gee teaches the nicotine containing article according to claim 1, as stated above. Black further discloses wherein the nicotine containing product is a tobacco product (“the inner filling material 6910 includes the plant material (e.g., . . . tobacco . . .)”, ¶ 0351).
Regarding claim 10, Black in view of Gee teaches the nicotine containing article according to claim 1, as stated above. Black further discloses wherein the nicotine containing product is a fibre which contains nicotine and/or is enriched with nicotine (“filling material 6910 includes a dry mixture and the liquid mixture, the liquid mixture including liquid nicotine . . . the dry mixture includes a non-tobacco cellulose material, and the liquid mixture is absorbed in the cellulose”, ¶ 0346).
Regarding claim 11, Black in view of Gee teaches the nicotine containing article according to claim 1, as stated above. Black further discloses wherein the nicotine containing product has a pasty consistency (“the oral product is a . . . paste”, ¶ 0200).
Regarding claim 12, Black in view of Gee teaches the nicotine containing article according to claim 1, as stated above. Black further discloses wherein the nicotine containing product has a moist consistency (“the oral pouch product 6800 maintains a relatively moist mouth feel, while maintaining a moisture content of about 4% to about 8%”, ¶ 0348).
Regarding claim 17, Black in view of Gee teaches the nicotine containing article according to claim 1, as stated above. Black further discloses wherein the cooling agent and the flavouring agent are mixed with nicotine (“liquid mixture including nicotine and a triglyceride”, ¶ 0336).
With regards to the cooling agent and the flavouring agent being mixed with nicotine before being applied to the part of the wrapping material, this limitation refers to the specific process by which the product is made. However, the patentability of a product does not depend on its method of production. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985); MPEP § 2113(I). In re Thorpe concerned a claimed product wherein the difference between the claimed and prior art products was the separate applications of metal oxide and carboxylic acid versus an application of a mixture of metal oxide and carboxylic acid. The court held that claimed product was unpatentable over the prior art because the end product is the same. Similarly, regardless of whether the cooling agent and flavouring agent of Black are mixed together with nicotine before application or applied separately, the end product is the same.
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.
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/C.G.C./Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747