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 .
Claim Objections
Claims 1, 62 and 66 are objected to because of the following informalities:
the phrase “0.1 percent to about 4 percent” should be changed to -- 0.1% to about 4% --.
Appropriate correction is requested.
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 35-37, 40, 43-44, 46-47, 49 and 71-72 are rejected under 35 U.S.C. 103 as being unpatentable over Cantrell et al (US. Pat. App. Pub. 2012/0138074) in view of Finberg (US. Pat. No. 3,067, 068).
Regarding independent claim 35, and dependent claims 36, 40, 43 and 44, Cantrell et al discloses a dissolvable smokeless tobacco composition configured for insertion into the mouth of a user, as opposed to being burned and the smoke from which inhaled. The composition may take the form of a tobacco-based pastille (see abstract and para. [0004]) (corresponding to the claimed “[a]n oral product for insertion into the mouth of a user of the product, the oral product comprising a base composition admixed with a tobacco material”; the “wherein the oral product is in the form of a pastille” recitation of claim 36; the “wherein the oral product is in the form of a meltable oral product” recitation of claim 40).
Cantrell et al explicitly discloses incorporating botanical and herbal materials selected from the group consisting of mint, spearmint, peppermint, wintergreen, lavender, cinnamon, clove, sage, licorice, ginger, orange, and eucalyptus (see para. [0037]). These botanical species directly overlap the Markush group of the instant independent claim 35 and dependent claims 71-72 (see MPEP 2131.02).
Cantrell et al does not explicitly specify that the tobacco material is present in an amount of about 0.1% to about 4% by weight, or that the botanical material is present in an amount of at least about 15% of the total dry weight of the oral product; however, Finberg discloses reduced-nicotine smokeless oral products wherein tobacco is present in low concentrations and non-tobacco botanical plant material (e.g., papaya leaf or herbal filters) is present as the predominant filler material in amounts that would exceed the claimed 15% dry weight (e.g., 50% to 95% dry weight), in order to reduce active nicotine intake while maintaining product volume and organoleptic satisfaction (see col. 1, lines 35-50; col. 2, lines 40-55). It would have been obvious to one having ordinary skill in the art as of the effective filing date of the claimed invention to modify the oral product composition of Cantrell et al by adjusting the relative weight ratios of tobacco and botanical ingredients to include 0.1% to 4% weight tobacco and at least 15% dry weight botanical material, as taught by Finberg, in order to provide a low-nicotine smokeless tobacco intake while maintaining desirable product organoleptic profile (see MPEP 2143). Applicant should note that selecting a specific low concentration range of 0.1-4% by weight for the tobacco component is a matter of routine optimization of a known result-effective variable (corresponding to the claimed “wherein the tobacco material is present in an amount of about 0.1 percent to about 4 percent by weight”).
Lastly, the modified Cantrell et al product inherently teaches an oral product comprising at least about 15% dry weight botanical material admixed with 0.1-4% tobacco. As such, the composition would have inherently possessed an ORAC index value of at least about 20 μmol TE/g and/or a FRAP index value of at least about 50 (μmol/Fe2+)/g. Under MPEP 2112, where the primary structural components and concentration ranges of a composition are rendered obvious by the prior art, the physical/chemical properties inherently resulting form that combination are also rendered obvious (corresponding to the claimed “wherein the oral product has an ORAC index value of at least about 20 μmol TE)/g or a FRAP index value of at least about 50 ( μmol/Fe2+)/g”; the “wherein the botanical material has an ORAC index value of at least about 250 μmol TE)/g or grater” recitation of claim 43; and the “wherein the botanical material has a FRAP index value of about 250 μmol/Fe2+)/g” recitation of claim 44).
Regarding claim 37, Cantrell et al discloses that its dissolvable smokeless tobacco pastille may have both a sugar alcohol component (at least about 20 dry weight percent) and a natural gum binder component (at least about 25 dry weight percent) (see paras. [0004],[0005],[0043] claim 17) (corresponding to the claimed “wherein the base composition is a pastille formulation comprising at least about 20 dry weight percent of a sugar alcohol and at least about 25 dry weight percent of a natural gum binder”).
Regarding claims 46 and 47, Cantrell discloses that the “tobacco” which comprises its composition may include particulate tobacco, but it also states that a portion (read: less than a majority/50%) of its tobacco material may take the form of a tobacco extract - either aqueous (liquid) or freeze-dried (read: particulate), thus resulting in a composition that comprises tobacco particulate material and tobacco extract material. In other words, Cantrell et al envisions a tobacco composition which would include as its “tobacco material” a portion (less than 50%) in the form of a tobacco extract (liquid or freeze-dried) and the remaining amount (read: greater than 50%) in the form of a tobacco particulate (see paras. [0004],[0028],[0066])(corresponding to the “wherein both the tobacco material and the botanical material are in particulate form” recitation of claim 46; and the “wherein at least one of the tobacco material and the botanical material are in the form of an oil or aqueous extract” recitation of claim 47)
Regarding claim 49, Cantrell et al discloses that its smokeless tobacco pastille may include any number of additives, including all of those which are claimed (see paras. [0004],[0006]-[0007],[0033]) (corresponding to the claimed “further comprising one or more additional components selected from the group consisting of flavorants, fillers, binders, pH adjusters, buffering agents, salts, sweeteners, colorants, disintegration aides, humectants, and preservatives).
Claims 38 is rejected under 35 U.S.C. 103 as being unpatentable over Cantrell et al (US. Pat. App. Pub. 2012/0138074) in view of Finberg (US. Pat. No. 3,067, 068), further in view of Williams (US. Pat. App. Pub. 2002/0162562).
Regarding claim 38, Cantrell discloses that its smokeless tobacco product can take the form of a pastille, and not specifically a lozenge. However, the “Background” section of the Williams et al reference shows that there are many oral delivery forms of tobacco, including lozenges (see para. [0004]). Hence, it would have been obvious to one having ordinary skill as of the effective filing date of the claimed invention to have chosen to form the Cantrell et al tobacco product in the form of a lozenge as such is already known in the art (corresponding to the claimed “wherein the oral product is in the form of a lozenge”).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Cantrell et al (US. Pat. App. Pub. 2012/0138074) in view of Finberg (US. Pat. No. 3,067, 068) and Williams (US. Pat. App. Pub. 2002/0162562), further in view of Suovaniemi et al (US. Pat. App. Pub. 2008/0000489).
The modified oral lozenge composition of Cantrell et al does not clearly show a sugar alcohol content of at least about 80% by weight; however, the Suovaniemi et al reference shows an oral composition intended to be sucked in the mouth of a user which, according to Examples 1 and 2, may have a sugar alcohol content in excess of 80% (see paras. [0017],[0100]-[0102]). 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 provided at least this percentage of sugar alcohol in the modified oral composition of Cantrell et al in order that it may serve as a diluent or filler, as well as a sweetening agent, to give the oral composition some added “bulk”, as taught in Suovaniemi et al (see para. [0069]) (corresponding to the claimed “wherein the base composition is a lozenge formulation comprising a sugar alcohol in an amount of at least about 80% by weight”).
Claims 41-42 and 62-64 are rejected under 35 U.S.C. 103 as being unpatentable over Cantrell et al (US. Pat. App. Pub. 2012/0138074) in view of Finberg (US. Pat. No. 3,067, 068), further in view of Cantrell et al (US. Pat. App. Pub 2012/0037175) (hereinafter referred to as “Cantrell et al ‘175”).
Regarding claims 41-42, as stated above, the modified Cantrell et al smokeless tobacco product is dissolvable, but it does not state that it is meltable nor that it comprises a lipid having the claimed parameters. However, Cantrell et al ‘175 discloses a meltable smokeless tobacco composition having lipids which meet these claim limitations. Specifically, it discloses a final smokeless tobacco composition which has 34 parts lipid, 29 parts filler (read: about 30%), and 36 parts tobacco - wherein the lipid has a melting point of about 35-45oC (see abstract, para. [0161]) 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 utilized the lipid disclosed in Cantrell et al ‘175 along with the disclosed filler, and add them to the modified Cantrell et al smokeless tobacco invention, in the disclosed amounts, as such components are known for use in smokeless tobacco compositions and the resulting meltable characteristics of said composition make it desirable and enjoyable for end users (corresponding to the “wherein the base composition is a meltable formulation comprising a lipid having a melting point of about 36o C to about 45o C” recitation of claim 41; and the “wherein the meltable formulation comprises the lipid in an amount of about 30% by weight, and a filler in an amount of about 30% by weight or greater” recitation of claim 42).
Regarding independent claim 62, and dependent claim 63, Regarding independent claim 35, and dependent claims 36, 40, 43 and 44, Cantrell et al discloses a dissolvable smokeless tobacco composition configured for insertion into the mouth of a user, as opposed to being burned and the smoke from which inhaled. The composition may take the form of a tobacco-based pastille (see abstract and para. [0004]) (corresponding to the claimed “[a]n oral product for insertion into the mouth of a user of the product, the oral product comprising a base composition admixed with a tobacco material”; the “wherein the oral product is in the form of a pastille” recitation of claim 36; the “wherein the oral product is in the form of a meltable oral product” recitation of claim 40).
Cantrell et al explicitly discloses incorporating botanical and herbal materials selected from the group consisting of mint, spearmint, peppermint, wintergreen, lavender, cinnamon, clove, sage, licorice, ginger, orange, and eucalyptus (see para. [0037]). These botanical species directly overlap the Markush group of the instant independent claim 35 and dependent claims 71-72 (see MPEP 2131.02).
Cantrell et al does not explicitly specify that the tobacco material is present in an amount of about 0.1% to about 4% by weight, or that the botanical material is present in an amount of at least about 15% of the total dry weight of the oral product; however, Finberg discloses reduced-nicotine smokeless oral products wherein tobacco is present in low concentrations and non-tobacco botanical plant material (e.g., papaya leaf or herbal filters) is present as the predominant filler material in amounts that would exceed the claimed 15% dry weight (e.g., 50% to 95% dry weight), in order to reduce active nicotine intake while maintaining product volume and organoleptic satisfaction (see col. 1, lines 35-50; col. 2, lines 40-55). It would have been obvious to one having ordinary skill in the art as of the effective filing date of the claimed invention to modify the oral product composition of Cantrell et al by adjusting the relative weight ratios of tobacco and botanical ingredients to include 0.1% to 4% weight tobacco and at least 15% dry weight botanical material, as taught by Finberg, in order to provide a low-nicotine smokeless tobacco intake while maintaining desirable product organoleptic profile (see MPEP 2143). Applicant should note that selecting a specific low concentration range of 0.1-4% by weight for the tobacco component is a matter of routine optimization of a known result-effective variable (corresponding to the claimed “wherein the tobacco material is present in an amount of about 0.1 percent to about 4 percent by weight”).
Further, the modified Cantrell et al product inherently teaches an oral product comprising at least about 15% dry weight botanical material admixed with 0.1-4% tobacco. As such, the composition would have inherently possessed an ORAC index value of at least about 20 μmol TE/g and/or a FRAP index value of at least about 50 (μmol/Fe2+)/g. Under MPEP 2112, where the primary structural components and concentration ranges of a composition are rendered obvious by the prior art, the physical/chemical properties inherently resulting form that combination are also rendered obvious (corresponding to the claimed “wherein the oral product has an ORAC index value of at least about 20 μmol TE)/g or a FRAP index value of at least about 50 ( μmol/Fe2+)/g”; the “wherein the botanical material has an ORAC index value of at least about 250 μmol TE)/g or grater” recitation of claim 43; and the “wherein the botanical material has a FRAP index value of about 250 μmol/Fe2+)/g” recitation of claim 44).
Lastly, as stated above, Cantrell et al discloses that its smokeless tobacco product is dissolvable, but it does not state that it is meltable nor that it comprises a lipid having the claimed parameters. However, Cantrell et al ‘175 discloses a meltable smokeless tobacco composition having lipids which meet these claim limitations. Specifically, it discloses a final smokeless tobacco composition which has 34 parts lipid, 29 parts filler (read: about 30%), and 36 parts tobacco - wherein the lipid has a melting point of about 35-45oC (see abstract, para. [0161]) 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 utilized the lipid disclosed in Cantrell et al ‘175 along with the disclosed filler, and add them to the modified Cantrell et al smokeless tobacco invention, in the disclosed amounts, as such components are known for use in smokeless tobacco compositions and the resulting meltable characteristics of said composition make it desirable and enjoyable for end users (corresponding to the “wherein the base composition is a meltable formulation comprising a lipid having a melting point of about 36o C to about 45o C, wherein the meltable formulation comprises the lipid in an amount of about 30% by weight, and a filler in an amount of about 30% by weight or greater”).
Regarding claims 63 and 65, Finberg discloses “yerba mate” as one of the vegetable fibers (read: botanical material) that are suitable for use in its tobacco-like composition. As such, 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 this particular material, as a matter of choice, as such is one of many that would provide for a low-nicotine smokeless product (corresponding to the claimed “wherein the botanical material is selected from the group consisting of…yerba mate”).
Regarding claim 64, as stated above, Cantrell et al discloses that its tobacco material and additives (which would also include the antioxidant) can be provided in powdered or granulated form (read: milled) (corresponding to the claimed “wherein the oral product is in the form of a pastille and wherein the botanical material is selected from…milled green tea”).
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Cantrell et al (US. Pat. App. Pub. 2012/0138074) - as evidenced by Kierulff et al (US. Pat. No. 6,298,859) - in view of Finberg (US. Pat. No. 3,067, 068).
Regarding claim 48, the tobacco material used in the modified Cantrell et al smokeless tobacco product may be provided in the form of an extract that can be obtained by extracting tobacco using any number of exemplary techniques, including that which is disclosed in Kierulff et al, which is incorporated by reference. Kierulff et al discloses that tobacco can be subjected to aqueous extraction such that the water-soluble phenolic compounds of the tobacco partitions into the aqueous extract, including nicotine (read: tobacco-derived nicotine solution) (see col. 3, line 55- col. 4, line 3) (corresponding to the claimed “wherein the tobacco material is a tobacco-derived nicotine solution”).
Claim 65 is rejected under 35 U.S.C. 103 as being unpatentable over Cantrell et al (US. Pat. App. Pub. 2012/0138074) in view of Finberg (US. Pat. No. 3,067, 068), further in view of Williams (US. Pat. App. Pub. 2002/0162562).
Regarding claim 65, not only may the modified Cantrell et al product take the form of a lozenge, it can also include a botanical/antioxidant material in the form of green tea (as discussed below) (corresponding to the claimed “wherein the oral product is in the form of a lozenge and wherein the botanical material is selected from…green tea”).
Claims 66-68 are rejected under 35 U.S.C. 103 as being unpatentable over Cantrell et al (US. Pat. App. Pub. 2012/0138074) in view of Finberg (US. Pat. No. 3,067, 068), further in view of Holton, Jr (US Pat. App. 2013/0312774).
Regarding independent claim 66, and dependent claim 68, Cantrell et al discloses a dissolvable smokeless tobacco composition configured for insertion into the mouth of a user, as opposed to being burned and the smoke from which inhaled. The composition may take the form of a tobacco-based pastille (see abstract and para. [0004]) (corresponding to the claimed “[a]n oral product for insertion into the mouth of a user of the product, the oral product comprising a base composition admixed with a tobacco material”).
Cantrell et al explicitly discloses incorporating botanical and herbal materials selected from the group consisting of mint, spearmint, peppermint, wintergreen, lavender, cinnamon, clove, sage, licorice, ginger, orange, and eucalyptus (see para. [0037]). These botanical species directly overlap the Markush group of the instant independent claim 35 (see MPEP 2131.02).
Cantrell et al does not explicitly specify that the tobacco material is present in an amount of about 0.1% to about 4% by weight, or that the botanical material is present in an amount of at least about 15% of the total dry weight of the oral product; however, Finberg discloses reduced-nicotine smokeless oral products wherein tobacco is present in low concentrations and non-tobacco botanical plant material (e.g., papaya leaf or herbal filters) is present as the predominant filler material in amounts that would exceed the claimed 15% dry weight (e.g., 50% to 95% dry weight), in order to reduce active nicotine intake while maintaining product volume and organoleptic satisfaction (see col. 1, lines 35-50; col. 2, lines 40-55). It would have been obvious to one having ordinary skill in the art as of the effective filing date of the claimed invention to modify the oral product composition of Cantrell et al by adjusting the relative weight ratios of tobacco and botanical ingredients to include 0.1% to 4% weight tobacco and at least 15% dry weight botanical material, as taught by Finberg, in order to provide a low-nicotine smokeless tobacco intake while maintaining desirable product organoleptic profile (see MPEP 2143). Applicant should note that selecting a specific low concentration range of 0.1-4% by weight for the tobacco component is a matter of routine optimization of a known result-effective variable (corresponding to the claimed “wherein the tobacco material is present in an amount of about 0.1 percent to about 4 percent by weight).
Cantrell et al discloses that the “tobacco” which comprises its composition may include a tobacco extract. The modified Cantrell et al oral product fails to disclose that this extract is in the form of “pharmaceutical grade tobacco”; however, the Holton, Jr reference shows that smokeless oral tobacco products are known that include tobacco extract that are in the form of highly purified nicotine wherein the high molecular weight components are removed in order to improve clarity (read: pharmaceutical grade nicotine) (see para. [0052]) 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 incorporate this type of tobacco extract into the oral product of the modified Cantrell et al product in order to provide a composition that is translucent or transparent in accordance to a particular design preference (corresponding to the claimed “wherein the tobacco material is in the form of an extract and wherein the extract is pharmaceutical grade nicotine”).
Regarding claim 67, the modified Cantrell et al product inherently teaches an oral product comprising at least about 15% dry weight botanical material admixed with 0.1-4% tobacco. As such, the composition would have inherently possessed an ORAC index value of at least about 20 μmol TE/g or a FRAP index value of at least about 50 (μmol/Fe2+)/g. Under MPEP 2112, where the primary structural components and concentration ranges of a composition are rendered obvious by the prior art, the physical/chemical properties inherently resulting form that combination are also rendered obvious (corresponding to the claimed “wherein the oral product has an ORAC index value of at least about 20 μmol TE)/g or a FRAP index value of at least about 50 ( μmol/Fe2+)/g”).
Regarding claim 68, Finberg discloses “yerba mate” as one of the vegetable fibers (read: botanical material) that are suitable for use in its tobacco-like composition. As such, 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 this particular material, as a matter of choice, as such is one of many that would provide for a low-nicotine smokeless product (corresponding to the claimed “wherein the botanical material is selected from the group consisting of…yerba mate”).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot in view of the new grounds for rejection, presented above, which were necessitated because of the amendments made to the claims, filed on July 20, 2026.
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 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
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