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 .
Response to Arguments
Applicant’s arguments, filed on December 11, 2025, with respect to the rejection of the instant claims over the prior art of record have been fully considered. While not acquiescing to Applicant’s assertions, the Examiner has withdrawn the previous prior art rejection. However, upon further consideration, new grounds of rejection are hereby being made in view of many of the same pieces of art in addition to other prior art presented as evidence, as follows:
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, 46-47, 49 and 66-70 are rejected under 35 U.S.C. 103 as being unpatentable over Cantrell et al (US. Pat. App. Pub. 2012/0138074) in view of Pera (US. Pat. App. Pub. 2003/0084912).
Regarding independent claim 35, and dependent claims 36, 40 and 47, 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 order 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 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 (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]). Further, while Cantrell et al discloses that its composition is comprised predominantly of a tobacco particulate (see para. [0029]), it also envisions an embodiment where the tobacco particulate component may be replaced with a botanical particulate, such as a tea or herbal particulate (see para. [0066]). Note, also, that Cantrell et al discloses that an anti-oxidant can be added to its composition (see para. [0033]). Cantrell et al stops short of naming the specific botanical particulate that may be utilized; however, the Pera reference discloses a smokeless tobacco composition, including ingredients in micro-powdered (read: particulate) form, and discusses the many benefits of including antioxidants (read: botanical materials) therein. Specifically, rosemary is listed as an antioxidant that can be used (see para. [0053]). 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 to include this particular herb for use as the botanical particulate component material in the smokeless tobacco composition of Cantrell et al in order to appreciate the health benefits of this material in offsetting the production of free radicals in the body, as taught in Pera (see paras. [0047],[0050]-[0058])(corresponding to the claimed “and a botanical material, wherein the botanical material is present in an amount of at least about 15% of the total dry weight of the oral product, wherein the botanical material is…rosemary”; 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).
Further, while neither Cantrell et al nor Pera disclose the ORAC or FRAP value of its tobacco product with a rosemary antioxidant included, based on the fact that rosemary exhibits ORAC/FRAP values that are very high (according to the instant written specification), and since the majority of the modified Cantrell et al composition would be comprised of the rosemary botanical material (in place of the particulate tobacco component), it follows that the resulting ORAC/FRAP value of the entire composition would have been consistent with that which is claimed, absent any evidence to the contrary. However, in the alternative, 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 optimized the rosemary antioxidant amount so as to render superior free-radical-scavenging ability, as taught in Pera, and, in so doing, would have resulted in a product having an ORAC or FRAP range consistent with that which is claimed (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 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 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).
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 order 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 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 (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]). Further, while Cantrell et al discloses that its composition is comprised predominantly of a tobacco particulate (see para. [0029]), it also envisions an embodiment where the tobacco particulate component may be replaced with a botanical particulate, such as a tea or herbal particulate (see para. [0066]). Note, also, that Cantrell et al discloses that an anti-oxidant can be added to its composition (see para. [0033]). Cantrell et al stops short of naming the specific botanical particulate that may be utilized; however, the Pera reference discloses a smokeless tobacco composition, including ingredients in micro-powdered (read: particulate) form, and discusses the many benefits of including antioxidants (read: botanical materials) therein. Specifically, rosemary is listed as an antioxidant that can be used (see para. [0053]). 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 to include this particular herb for use as the botanical particulate component material in the smokeless tobacco composition of Cantrell et al in order to appreciate the health benefits of this material in offsetting the production of free radicals in the body, as taught in Pera (see paras. [0047],[0050]-[0058])(corresponding to the claimed “and a botanical material, wherein the botanical material is present in an amount of at least about 15% of the total dry weight of the oral product, wherein the botanical material is…rosemary”; and the “wherein the botanical material is selected form the group consisting of…rosemary” recitation of claim 68).
Regarding claim 67, while neither Cantrell et al nor Pera disclose the ORAC or FRAP value of its tobacco product with a rosemary antioxidant included, based on the fact that rosemary exhibits ORAC/FRAP values that are very high (according to the instant written specification), and since the majority of the modified Cantrell et al composition would be comprised of the rosemary botanical material (in place of the particulate tobacco component), it follows that the resulting ORAC/FRAP value of the entire composition would have been consistent with that which is claimed, absent any evidence to the contrary. However, in the alternative, 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 optimized the rosemary antioxidant amount so as to render superior free-radical-scavenging ability, as taught in Pera, and, in so doing, would have resulted in a product having an ORAC or FRAP range consistent with that which is claimed (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 69, Cantrell et al discloses that a portion of its composition can include tobacco in the form of an extract, which means that in the embodiment wherein the tobacco particulate component is substituted with botanical material, the remaining tobacco material would be provided in a smaller amount, i.e. a portion - which means that it would be up to one having ordinary skill in the art to determine what percentage of the overall product that tobacco material would comprise. 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 undergone routine experimentation to determine the optimal amount of tobacco extract and arrived at the claimed amount after determining that said amount provided a superior organoleptic experience for the user (corresponding to the “wherein the tobacco material is present in an amount of about 0.1 percent to about 4 percent by weight” recitation of claim 69 and the “wherein the tobacco material is present in the form of a tobacco extract” recitation of claim 70”).
Claims 38 and 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 Pera (US. Pat. App. Pub. 2003/0084912), 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 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”).
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”).
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 Pera (US. Pat. App. Pub. 2003/0084912) 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 in view of Pera (US. Pat. App. Pub. 2003/0084912), 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, 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” recitation of claim 42; 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, 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 order 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 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 (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]). Further, while Cantrell et al discloses that its composition is comprised predominantly of a tobacco particulate (see para. [0029]), it also envisions an embodiment where the tobacco particulate component may be replaced with a botanical particulate, such as a tea or herbal particulate (see para. [0066]). Note, also, that Cantrell et al discloses that an anti-oxidant can be added to its composition (see para. [0033]). Cantrell et al stops short of naming the specific botanical particulate that may be utilized; however, the Pera reference discloses a smokeless tobacco composition, including ingredients in micro-powdered (read: particulate) form, and discusses the many benefits of including antioxidants (read: botanical materials) therein. Specifically, green tea is listed as an antioxidant that can be used (see para. [0053]). 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 to include this particular herb for use as the botanical particulate component material in the smokeless tobacco composition of Cantrell et al in order to appreciate the health benefits of this material in offsetting the production of free radicals in the body, as taught in Pera (see paras. [0047],[0050]-[0058])(corresponding to the claimed “and a botanical material, wherein the botanical material is present in an amount of at least about 15% of the total dry weight of the oral product, wherein the botanical material is…green tea”; and the “wherein the botanical material is selected from the group consisting of…green tea” recitation of claim 63).
Further, while neither Cantrell et al nor Pera disclose the ORAC or FRAP value of its tobacco product with a rosemary antioxidant included, based on the fact that green tea exhibits ORAC/FRAP values that are very high (according to the instant written specification), and since the majority of the modified Cantrell et al composition would be comprised of the green tea botanical material (in place of the particulate tobacco component), it follows that the resulting ORAC/FRAP value of the entire composition would have been consistent with that which is claimed, absent any evidence to the contrary. However, in the alternative, 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 optimized the green tea antioxidant amount so as to render superior free-radical-scavenging ability, as taught in Pera, and, in so doing, would have resulted in a product having an ORAC or FRAP range consistent with that which is claimed (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”).
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 claim 64, as sated 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 form…milled green tea”)
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Cantrell et al (US. Pat. App. Pub. 2012/0138074) in view of Pera (US. Pat. App. Pub. 2003/0084912) - as evidenced by dr-barbara-hendel.com’s web article (“ORAC values of selected foods”), hereinafter referred to as the “Dr Barbara Hendel article”).
Regarding claim 43, while the modified Cantrell et al tobacco product is silent as to the ORAC value of the rosemary in its smokeless tobacco composition, the Dr Barabara Hendel article serves as evidence that rosemary clearly exhibits an ORAC value consistent with that which is claimed (corresponding to the claimed “wherein the botanical material has an ORAC index value of at least about 250 (μmol TE)/g or greater”).
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Cantrell et al (US. Pat. App. Pub. 2012/0138074) in view of Pera (US. Pat. App. Pub. 2003/0084912) - as evidenced by Atilla Kiss et al’s article “Comparative Study on Antioxidant Capacity of Diverse Food Matrices: Applicability, Suitability and Inter-Correlation of Multiple Assays to Assess Polyphenol and Antioxidant Status”, hereinafter referred to as “Kiss et al”.)
Regarding claim 44, while the modified Cantrell et al tobacco product is silent as to the FRAP value of the rosemary in its smokeless tobacco composition, Kiss et al serves as evidence that rosemary clearly exhibits an FRAP value consistent with that which is claimed (corresponding to the claimed “wherein the botanical material has a FRAP index value of at about 250 (μmol/FE2+)/g or greater”).
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 in view of Pera (US. Pat. App. Pub. 2003/0084912).
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”).
Conclusion
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/DIONNE W. MAYES/Primary Examiner, Art Unit 1747