The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Election/Restrictions
Newly submitted claims 22 and 24 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the claims to the different species recite the mutually exclusive characteristics of such species, and provide a description of the mutually exclusive characteristics of each species.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 22 and 24 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1-3, 11-13, 15-21 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Atchley et al. (U.S Pub. No. 20100163062) in view of Hodin et al. (WO 2009082331) and Atchley et al. (U.S Pub. No. 20120031414) and further in view of Mua et al. (U.S Pub. No. 20090025738).
Regarding claim 1, Atchley discloses an oral product comprising:
a silicone binder; tobacco or reconstituted tobacco which includes cellulose fibers and the cellulose fibers dispersed within the silicone binder wherein nicotine absorbed in the cellulose fibers (figs. 1-8 and [0029] [0030][0109]). Hodin discloses oral product with either tobacco or non-tobacco plant material having fibrous structures wherein the non-tobacco plant fibers can be used in the same way as an oral tobacco product (page 4, lines 26-31). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to use a non-tobacco plant fibers instead of a tobacco plant fibers as taught by Hodin.
Atchley (’62) doesn’t expressly the product comprises an oven volatiles. Atchley (’14) discloses the oven volatiles content can be between 48-50 weight percent [0102] [0106] overlapping with the claimed range. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to pick the claimed range.
Atchley does not expressly disclose the oral product comprising a flavor strip. Mua discloses an oral product including flavor strip [0037-0038]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to provide flavor to the oral product of Atchley in form of a flavor strip as taught by Mua.
Regarding claim 2, it would have been obvious to one of ordinary skill in the art at the time the invention was made that the nicotine includes tobacco-derived nicotine. Furthermore, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695,698, 227 USPQ 964, 966 (Fed. Cir. 1985), (MPEP 2113). In this case the claimed nicotine is the same as or obvious from the nicotine of Atchley.
Regarding claim 3, it would have been obvious to one of ordinary skill in the art at the time the invention was made that the nicotine includes synthetic nicotine. Furthermore, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695,698, 227 USPQ 964, 966 (Fed. Cir. 1985), (MPEP 2113). In this case the claimed nicotine is the same as or obvious from the nicotine of Atchley.
Regarding claim 11, in additions to the features discussed above for claim 1, Atchley discloses the product further comprising: an integrally-molded mixture including, the silicone binder, the cellulose fibers, and the nicotine [0037].
Regarding claims 12-13, Atchley discloses a ratio of tobacco to polymer by weight [0006] [0029] [0037] overlapping with the claimed range of the weight percentage of the elastic silicone binder.
Regarding claim 15, Atchley discloses the product further comprising: a flavorant [0034].
Regarding claim 16, Atchley (’14) discloses the product comprising soluble fibers [0113].
Regarding claim 17, Atchley discloses the product further comprising a filler including starch, di-calcium phosphate, lactose, sorbitol, mannitol, and microcrystalline cellulose, or any combination thereof [0036]-[0039].
Regarding claim 18, Atchley discloses the product further comprising: a sweetener [0034].
Regarding claim 19, Hodin discloses the oral product can be free of tobacco (Abstract).
Regarding claim 20, Atchley (’14) discloses the product with sizes overlapping with the claimed ranges (claim 61).
Regarding claim 21, Atchley (’14) discloses the oral product further comprising a film at least partially wrapped around an exterior of the oral product, wherein the film is configured to dissolve when placed into an oral cavity of an adult user [0094] [0119]. Furthermore, if it is determined that the film of Atchley (fig. 12 B) is not transparent, with a finite number of types (transparent/translucent/opaque) of film; it would have been obvious to one of ordinary skill in the art at the time the invention was made to try.
Regarding claim 23, in addition to the features discussed above for claims 1 and 21, it would have been obvious to one of ordinary skill in the art at the time the invention was made that the film can be a transparent film (see figs. 12B and [0119]. Furthermore, given a limited
Claims 4-7, 14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Atchley et al. (U.S Pub. No. 20100163062) in view of Hodin et al. (WO 2009082331), Atchley et al. (U.S Pub. No. 20120031414) and Mua et al. (U.S Pub. No. 20090025738) as applied to claim 1 above and further in view of and Kuo (Polydimethylsiloxane, Polymer Data Handbook).
Regarding claims 4-7, Atchley discloses a silicone smokeless tobacco product comprising smokeless tobacco and an elastic silicone binder [0029] ; furthermore it is well known (as evidenced by the Kuo) that polydimethylsiloxane (PDMS) belongs to a group commonly referred to as silicones. PDMS is widely used silicone for its special properties such as thermal stability, physiological inertness; therefore it would have been obvious to one of ordinary skill in the art at the time the invention was made to pick polydimethylsiloxane for its special properties.
Regarding claim 14, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695,698, 227 USPQ 964, 966 (Fed. Cir. 1985), (MPEP 2113). In this case the silicone binder is expected to be cross-link since the smokeless tobacco is expected to have water present; therefore the claimed invention is the same as or obvious from the product as disclosed by Atchley. Furthermore, it is also noted that Atchley discloses silicones can be silicone fluids and elastomers [0029] and Kuo discloses polydimethylsiloxane in elastomers form can have cross-linked structure.
Claim 19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Atchley et al. (U.S Pub. No. 20100163062) in view of Hodin et al. (WO 2009082331), Atchley et al. (U.S Pub. No. 20120031414) and Mua et al. (U.S Pub. No. 20090025738) as applied to claim 1 above and further in view of Axelsson et al. (U.S Pub. No. 20100004294). Atchley does not expressly discloses the oral product is free of tobacco. Axelsson discloses nicotine-cellulose combination as a tobacco substitute [007] [0011]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to use a tobacco substitute as taught by Axelsson.
Response to Arguments
Applicant’s arguments filed 9/17/2025 have been considered but are moot in view of the new ground of rejection.
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 PHU H NGUYEN whose telephone number is (571)272-5931. The examiner can normally be reached M-F 9-5.
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/PHU H NGUYEN/Examiner, Art Unit 1747
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