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 .
Status of the Claims
Claims 1-20 are pending and are subject to this Office Action. This is the first Office Action on the merits of the claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 and 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 12-14, 16 and 19 are rejected for their dependency on claims 2 and 11.
Claim 2, lines 2-3 are indefinite for reciting “the saturated fatty acids are a single substance and the esters of the saturated fatty acids are a single substance” because it is unclear what is meant by “single substance”. The instant Specification recites “single substances in the present invention include pure compounds and compounds containing unavoidable impurities” ([0018]). The instant Specification further recites the saturated fatty acid is palmitic acid ([0018]). However, as disclosed in Stevens even “extra pure” palmitic acid comprises about 5% stearic acid (column 4, lines 45-49) and therefore pure saturated fatty acids such as palmitic acid do not exist as single substances. Therefore “single substance” is indefinite because even pure substances with unavoidable impurities are not single substances. For purposes of examination, “single substance” is being interpreted as a majority a single substance.
Claim 11, lines 3-4 are indefinite for reciting “and a medium such that the powder is maintained in a powder state” because it is unclear how the medium is used in such a way that the powder is maintained in a powder state. The instant Specification discloses water or hydrophilic organic solvents are mediums that are used to mix the powder to form a liquid mixture ([0031]-[0032]) and thus it is not clear how a liquid medium mixed with a powder could maintain the powder form. Since there is no disclosure provided that explains how the powder is maintained in a powder state, the claim is indefinite. For purposes of examination, the medium is being interpreted as water and there is no requirement that mixing water with a powder creates a powder.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 10, and 13 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Stevens et. al (US-3729009-A, as cited in the IDS dated 11/15/2023).
In regards to claim 1, Stevens directed to a smoking product with improved flavor, discloses the smoking product including a substantial portion tobacco material (i.e., tobacco composition) (abstract) comprising:
(A) a tobacco material (column 1, lines 21-60); and
(B) a saturated fatty acid additive (column 1, lines 61-66),
Wherein:
The component (B) is a saturated fatty acid, preferably palmitic acid (column 3, lines 65-68 – column 4, lines 1-3), which is one of the listed preferable saturated fatty acids used in the tobacco composition of the instant Specification ([0018]) and thus would have a molar mass of 200 to 350 g/mol since it has been acknowledged by the Applicant as a suitable saturated fatty acid. Therefore, Palmitic acid would reasonably read on a molar mass within the claimed range of 200 to 350g/mol.; and
The tobacco composition contains the component (B) (the fatty acid) in an amount from 1.0 to 4 percent of the sheet, by weight (column 3, lines 19-21). Stevens further discloses an embodiment wherein the fatty acid is 1.2 weight percent of the composition after drying (column 5, lines 39-55). The component (B) has a mass percent per dry weight within the claimed range of 0.01 to 3%.
In regards to claim 2, Stevens discloses extra pure palmitic acid is used which is 95% palmitic acid and 5% stearic acid (column 4, lines 45-49) (i.e., primarily a single substance).
The examiner notes that the esters of the saturated fatty acids are an optional limitation and not a requirement of claim 1, therefore Stevens is not required to teach “esters of the saturated fatty acids are a single substance.”
In regards to claim 3, Stevens discloses the saturated fatty acid moiety is 16 to 18 carbon atoms (column 1, lines -61-66). Stevens teaches a saturated fatty acid moiety within the claimed range of 12 to 20 carbon atoms.
In regards to claim 10, Stevens discloses the tobacco composition is formed into a sheet (column 3, line 1).
In regards to claim 13, Stevens discloses the saturated fatty acid moiety is 16 to 18 carbon atoms (column 1, lines -61-66). Stevens teaches a saturated fatty acid moiety within the claimed range of 12 to 20 carbon atoms.
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.
Claims 4-9 and 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stevens et. al (US-3729009-A, as cited in the IDS dated 11/15/2023) as applied to claim 1 above, and further in view of Abi et al. (US-20230320406-A1).
In regards to claims 4 and 14-15, Stevens discloses the use of additives, but does not explicitly disclose the composition further comprising a liquid sugar at 1 to 10% mass per dry weight in the composition.
Abi, directed to an aerosol-generating material for use in aerosol generation, discloses the aerosol-generating material comprises tobacco (i.e., tobacco composition) ([0098]).
Abi further discloses the composition can comprises flavorants, additives, active agents like caffeine and nicotine, and acids (abstract, [0112], and [0119]).
Abi further discloses the flavorant in a weight percent from at least 0.1% to about 40% on a dry weight basis ([0119]) and the flavorant can include sugar or sugar substitutes and can be in the form of a liquid such as an oil (i.e., liquid sugar) ([0120]). The range disclosed by the prior art overlaps the claimed range of liquid sugar at 1 to 10mass% per dry weight in the composition and is therefore considered prima facie obvious.
Abi further discloses flavorants such as sugar, are used to create a desired taste, aroma, or other somatosensorial sensation for the consumer ([0120]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Stevens by making the tobacco composition further comprise liquid sugar from 1 to 10 mass%, as taught by Abi because both are directed to tobacco compositions for smoking articles, Abi teaches flavorants like sugar enhance the taste and sensations for the user ([0120]), and this merely involves applying a known technique of using a flavorant of a similar smoking composition to yield predictable results.
In regards to claims 5 and 16-18, Stevens discloses tobacco lamina scrap, tobacco dust, and stems (column 4, lines 36-40) but is silent to the type of tobacco used in the composition and therefore does not disclose the tobacco material (component (A)) is derived from an oriental species at 10 mass% or less.
Abi, directed to an aerosol-generating material for use in aerosol generation, discloses the aerosol-generating material comprises tobacco (i.e., tobacco composition) ([0098]).
Abi further discloses the tobacco material (Component (A)) can include oriental tobacco ([0400]) and the tobacco material is anywhere from 1 to 65 dry weight percent of the entire composition ([0110]). The range disclosed by the prior art overlaps the claimed range of the Component A contains a material derived from an oriental species at 10 mass% per dry weight or less in the composition and is therefore considered prima facie obvious.
Therefore, before the effective filling date of the claimed invention, it would be obvious
to modify Stevens by making the tobacco an oriental species comprising 10 mass% dry weight or less of the total composition, as taught by Abi, because one of ordinary skill in the art would look to a similar reference for a known type of tobacco material and a common weight percent for similar tobacco compositions, especially when the prior art is silent to specific types of tobacco and their weight percentages, and this merely involves applying known weight percents and a known form of tobacco of a similar composition to yield predictable results.
In regards to claims 6 and 19-20, Stevens discloses the composition comprises additives that contribute to excellent flavor (column 4, lines 61-68 – column 5, lines 1-15), but does not explicitly disclose a natural plant flavoring agent at 0.5 to 3 mass% per dry weight in the composition.
Abi, directed to an aerosol-generating material for use in aerosol generation, discloses the aerosol-generating material comprises tobacco (i.e., tobacco composition) ([0098]).
Abi further discloses the composition can comprises flavorants, additives, active agents like caffeine and nicotine, and acids (abstract, [0112], and [0119]).
Abi further discloses the flavorant in a weight percent from at least 0.1% to about 40% on a dry weight basis ([0119]) and the flavorant can include botanicals such as licorice (i.e., natural plant flavor, which is in line with the instant specifications definition of natural plant flavor) ([0120]). The range disclosed by the prior art overlaps the claimed range of a natural plant flavoring at 0.5 to 3 mass% per dry weight in the composition and is therefore considered prima facie obvious.
Abi further discloses flavorants such as sugar, are used to create a desired taste, aroma, or other somatosensorial sensation for the consumer ([0120]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Stevens by making the tobacco composition further comprise a natural plant flavoring, as taught by Abi because both are directed to tobacco compositions for smoking articles, Abi teaches flavorants like licorice enhance the taste and sensations for the user ([0120]), and this merely involves applying a known technique of using a flavorant of a similar smoking composition to yield predictable results.
In regards to claim 7, Stevens discloses the composition comprising tobacco (column 4, lines 36-40), but does not explicitly disclose the composition comprises nicotine at 2 mass% or more per dry weight in the composition.
Abi, directed to an aerosol-generating material for use in aerosol generation, discloses the aerosol-generating material comprises tobacco (i.e., tobacco composition) ([0098]).
Abi further discloses the aerosol-generating material comprises nicotine from 1 to 20 wt% calculated on a dry weight basis ([0111]). The range disclosed by the prior art overlaps the claimed range of nicotine at 2 mass% or more per dry weight in the composition and is therefore considered prima facie obvious.
Abi further discloses the tobacco extract is what contains the nicotine concentration and has a concentration from 1 to 20 wt% ([0111]).
Therefore, before the effective filling date of the claimed invention, it would be obvious to modify Stevens by making the tobacco composition comprise nicotine at 2 mass% or greater, as taught by Abi, because one of ordinary skill in the art would look to a similar reference for a known concentration of nicotine for similar tobacco compositions, especially when the prior art is silent to a specific nicotine concentration present in the tobacco material, and since the prior art teaches a similar tobacco extract which is known to have a certain nicotine concentration, this merely involves applying a known amount of nicotine of a similar tobacco extract of a similar composition to yield predictable results.
In regards to claim 8, Stevens discloses the composition comprising tobacco (column 4, lines 36-40), but does not explicitly disclose the composition comprises nicotine at 1.5 mass% or less per dry weight in the composition.
Abi, directed to an aerosol-generating material for use in aerosol generation, discloses the aerosol-generating material comprises tobacco (i.e., tobacco composition) ([0098]).
Abi further discloses the aerosol-generating material comprises nicotine from 1 to 20 wt% calculated on a dry weight basis ([0111]). The range disclosed by the prior art overlaps the claimed range of nicotine at 1.5 mass% or less per dry weight in the composition and is therefore considered prima facie obvious.
Abi further discloses the tobacco extract is what contains the nicotine concentration and has a concentration from 1 to 20 wt% ([0111]).
Therefore, before the effective filling date of the claimed invention, it would be obvious to modify Stevens by making the tobacco composition comprise nicotine at 1.5 mass% or less, as taught by Abi, because one of ordinary skill in the art would look to a similar reference for a known concentration of nicotine for similar tobacco compositions, especially when the prior art is silent to a specific nicotine concentration present in the tobacco material, and since the prior art teaches a similar tobacco extract which is known to have a certain nicotine concentration, this merely involves applying a known amount of nicotine of a similar tobacco extract of a similar composition to yield predictable results.
In regards to claim 9, Stevens does not explicitly disclose an aerosol-source material at 12 mass% or less per dry weight in the composition.
Abi, directed to an aerosol-generating material for use in aerosol generation, discloses the aerosol-generating material comprises tobacco (i.e., tobacco composition) ([0098]).
Abi further discloses the composition further comprises an aerosol-former material (i.e., aerosol-source material) which comprises one or more constituent capable of forming an aerosol ([0086]).
Abi further discloses the aerosol-source material is from 10 to 50 mass% dry weight in the composition ([0087]). The range disclosed by the prior art overlaps the claimed range of an aerosol-source material at 12 mass% or less per dry weight in the composition and is therefore considered prima facie obvious.
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Stevens by making the tobacco composition further comprise an aerosol-source material, as taught by Abi because both are directed to tobacco compositions for smoking articles, Abi teaches the aerosol-former material comprises constituents for forming an aerosol ([0086]), and this merely involves applying a known technique of applying an aerosol-source material of a similar smoking composition to yield predictable results.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Stevens et. al (US-3729009-A, as cited in the IDS dated 11/15/2023) as applied to claim 1 above and further in view of Frey et al. (https://pmc.ncbi.nlm.nih.gov/articles/PMC2838675/).
In regards to claim 11, Stevens discloses a method of manufacturing the tobacco composition of claim 1, the method comprising:
Preparing a slurry of the tobacco material, component (A) (column 2, lines 60-63),
A saturated fatty acid in “whatever form they may be employed” (column 3, lines 20-24), and
Water (i.e., a medium) (column 2, lines 53-64 - column 3, lines 1-17)
Stevens discloses the powdered tobacco is mixed with the saturated fatty acid prior to casting (column 3, lines 42-62) and it can be in whatever form (column 3, lines 20-24) but does not explicitly disclose the component (B) is a powder.
Frey directed to the function importance of the NH2 terminal insertion sequence of lung surfactant protein B discloses the materials used include palmitic acid in the powder form (page 3, paragraph 2).
Since Frey teaches it is known in the art that saturated fatty acids like palmitic acid are sold in the powder form, it would be obvious to one of ordinary skill in the art that Stevens would teach palmitic acid (Component (B)) as a powder, because Stevens already discloses the tobacco is in a powdered form, Stevens further teaches the Component B can be in any form (column 3, lines 20-24), and Frey teaches it is known in the art to sell palmitic acid as a powder (Frey page 3, paragraph 2). Therefore it would be prima facie obvious that Stevens in view of Frey would teach palmitic acid (Component (B)) is at least partially in the form of a powder.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Stevens et. al (US-3729009-A, as cited in the IDS dated 11/15/2023) in view of Frey et al. (https://pmc.ncbi.nlm.nih.gov/articles/PMC2838675/), as applied to claim 11 above, and further in view of Schmidt et al. (US-4144894-A).
In regards to claim 12, Stevens discloses the tobacco composition comprises a binder within the slurry (column 5, lines 40-46), but is silent to the viscosity of the slurry being from 100,000 to 200,000 mPa.s.
Stevens further discloses after mixing Component A with Component B with a binder, the mixture was spread to form a film of such thickness that after drying a dry film was obtained which approximated the thickness and weight of natural tobacco (column 5, lines 39-60).
While Stevens does not explicitly disclose the viscosity being adjust to 100,000 to 200,000 mPa.s, it would have been obvious to one of ordinary skill in the art at the time the invention was made to optimize the viscosity of the slurry since it has been held that, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The burden is upon the Applicant to demonstrate that the claimed viscosity is critical and has unexpected results. In the present invention, one would have been motivated to optimize the viscosity motivated by the desire to create a desired thickness of the slurry, such as a thickness similar to the thickness and weight of natural tobacco (column 5, lines 39-60).
In addition, Schmidt directed to a reconstituted tobacco composition and process for manufacturing the reconstituted tobacco composition, discloses castable tobacco slurries with a range of viscosities responsive to temperature (column 2, lines 35-44).
Schmidt further discloses the addition of tamarind gum (i.e., binder) creates a greater viscosity that is developed in the course of drying and prevents heat-cracking of the tobacco during drying (column 2, lines 45-50).
Schmidt further discloses the viscosity of the tobacco slurry can be from 500 to 500,000 centipoises (column 4, lines 58-65). It is noted that 1 centipoises is equal to 1 mPa.s. The range disclosed by the prior art overlaps the claimed range of adjusting the viscosity of the slurry to 100,000 to 200,000 mPa.s and is therefore considered prima facie obvious.
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Stevens by making the tobacco compositions binder tamarind gum to have a viscosity as claimed, as taught by Schmidt because both are directed to tobacco compositions for smoking articles, Schmidt teaches the addition of tamarind gum creates a greater viscosity which prevents heat-cracking of the tobacco during drying (column 2, lines 45-50), and this merely involves applying a known binder to adjust the viscosity to a known value of a similar smoking composition to yield predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELEINE PAULINA DELACRUZ whose telephone number is (703)756-4544. The examiner can normally be reached Monday - Friday 8-5.
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/MADELEINE P DELACRUZ/Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755