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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-11 drawn to an aerosol-generating material, in the reply filed on 12/03/2025 is acknowledged. The traversal is on the ground(s) that there is no undue burden to examine all of the claims of the application. This is not found persuasive because “undue burden” is primarily of issue in US practice restrictions, whereas this restriction was based upon the inventions lacking unity of invention (because of the application filed as PCT). Regardless, an examination of all of the separate groups would be considered to be an undue burden, as the separate groups containing divergent subject matter and are tied to different inventive categories, such that Group I lacks unity of invention with each of the separate groups identified and would need additional search. Applicant argues that a separate examiner examined all of the claims in the case, but this is not a persuasive showing for establishing unity of invention between the groups or for undue burden.
Applicant further argues that the claims contribute a special technical feature that makes a contribution over Franke. Applicant argues that Franke does not disclose the expansion agent which expands on contact with moisture to cause movement of the tobacco granules and expose further tobacco material. The Examiner respectfully disagrees. While Franke may not explicitly state that the tobacco granules leads to the expansion on contact with moisture, it is considered, the claimed property would implicitly be achieved, as "When the claimed and prior art products of identical or substantially identical in structure or composition, a prima facie case of obviousness has been established”, see MPEP 2112.01 I. And further, "Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present”, see MPEP 2112.01 II. In this case, Franke specifically contains tobacco granules, and may have any of the component of carboxymethylcellulose [0011, 0068], wherein these components are art recognized (and identified in the instant application) to have an expanding effect on contact with moisture. It is reasonably suggested by Franke that the tobacco composition thereof would have the expansion agent expanding on contact with moisture to cause movement of the tobacco granules and expose further tobacco material.
The requirement is still deemed proper and is therefore made FINAL.
Claims 12-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/03/2025.
Claims 5-6 and 9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/03/2025.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 7/13/2023, 9/27/2024, 8/11/2025 have been considered by the Examiner.
Claim Objections
Claim 11 is objected to because of the following informalities:
Claim 11 should read “…wherein the tobacco material has the pH of from…”. This would clarify that the same tobacco material from claim 10 is referred to, and the pH should be “the” because it was introduced in claim 10 of which claim 11 depends.
Appropriate correction is required.
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, 10-11 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.
Claim 2 recites “…from about 5% to about 50% by weight of the expansion agent”. Because of the use of “about’ to describe the claimed range, it is not clear what the actual claimed range would encompass at each of these endpoints. The written specification does not clarify what is meant by “about”, such that a person of ordinary skill in the art would not be able to ascertain what is considered “about 5%”. See MPEP 2173.05 (b). The court held that claims reciting "at least about" were invalid for indefiniteness where there was close prior art and there was nothing in the specification, prosecution history, or the prior art to provide any indication as to what range of specific activity is covered by the term "about." Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991). The claim will be examined such that the range is from 5% to 50%.
Claim 10 recites “the tobacco material has a pH of at least about 7. Because of the use of “about’ to describe the claimed range, it is not clear what the actual claimed range would encompass at each of these endpoints. The written specification does not clarify what is meant by “about”, such that a person of ordinary skill in the art would not be able to ascertain what is considered “at least about 7”. See MPEP 2173.05 (b). The court held that claims reciting "at least about" were invalid for indefiniteness where there was close prior art and there was nothing in the specification, prosecution history, or the prior art to provide any indication as to what range of specific activity is covered by the term "about." Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991). Claim 11 is rejected for relying upon a rejected claim. The claim will be examined such that the pH is at least 7.
Claim 11 recites “the tobacco has a pH of from about 8 to about 9.5 or from about 8.5 to about 9”. Because of the use of “about’ to describe the claimed range, it is not clear what the actual claimed range would encompass at each of these endpoints. The written specification does not clarify what is meant by “about”, such that a person of ordinary skill in the art would not be able to ascertain what is considered the specific claimed ranges. See MPEP 2173.05 (b). The court held that claims reciting "at least about" were invalid for indefiniteness where there was close prior art and there was nothing in the specification, prosecution history, or the prior art to provide any indication as to what range of specific activity is covered by the term "about." Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991). The claim will be examined such that the pH is from 8 to 9.5.
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 1-4, 7-8, 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Lampe (US2015/0230515A1).
Regarding claim 1, Lampe teaches an aerosol-generating material (smokeless tobacco gel type composition [0001-0004]) comprising tobacco granules comprising tobacco material (the gel may include tobacco material such as particulate tobacco material [0019, 0029], which are considered types of granules), and an expansion agent (the composition may include one or more additional components, include carboxymethylcellulose (CMC) [0049], disintegration or compressibility aids such as microcrystalline cellulose (MCC) or croscarmellose sodium (CCS) [0049]. It is noted that the instant application lists each of these three components as preferred examples of the expansion agent [see pg. 4-5 of instant specification, claim 3]. These components may each be provided in a powder form, granulated form, liquid form, etc. [0050], and Lampe’s composition/products may utilize any variety of shape/form/size/weight/consistency/etc. [0060]. Lampe identifies moisture control as an important aspect of this product [0063]).
Lampe does not explicitly state that the components of CMC, MCC, and/or CCS expand on contact with moisture to cause movement of the tobacco granules within the aerosol-generating material exposing further tobacco material. However, It is considered, the claimed property would implicitly be achieved, as "When the claimed and prior art products of identical or substantially identical in structure or composition, a prima facie case of obviousness has been established”, see MPEP 2112.01 I. And further, "Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present”, see MPEP 2112.01 II. In this case, Lampe specifically contains tobacco granules, and may have any of the components of CMC, MCC, and/or CCS, wherein these components are art recognized (and identified in the instant application) to have an expanding effect on contact with moisture. Additionally, in the case of CMC, Lampe specifies that the weight of the binder (of which CMC is classified as) may range from 5-50% by weight of the overall composition [0049, 0055], such that the preferred weight range is satisfied (see Claim 2). And lastly, as the instant specification suggests that essentially any number of physical relations between the tobacco granules and expansion agent results in the claimed property (see claims 4-7 and 9, and pg. 5 of the instant specification, wherein the expansion agent may be arranged inside, outside, between, or throughout the tobacco granules), it is reasonably suggested by Lampe that the tobacco composition thereof would have the expansion agent expanding on contact with moisture to cause movement of the tobacco granules and expose further tobacco material.
Regarding claim 2, Lampe makes obvious 5-50% by weight of the expansion agent (as in the rejection of claim 1 above, Lampe suggests that the amount of binder (which may be CMC) may range from 5-50% by weight of the overall composition [0049, 0055]. As carboxymethyl cellulose (CMC) is one of the preferred expansion agents, the claimed range is clearly suggested by Lampe. As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
Regarding claim 3, Lampe makes obvious the expansion agent selected from the group consisting of CMC, MCC, and CCS (as in the rejection of claim 1 above, the composition may include components of carboxymethylcellulose [0049], and/or microcrystalline cellulose (MCC) or croscarmellose sodium (CCS) [0049]).
Regarding claim 4, Lampe makes obvious at least some of the expansion agent is included within the tobacco granules (Lampe states that the tobacco may be provided as particulate [0005], as well as the expansion agents may be provided in powder/granulated/liquid/etc. form mixed with the tobacco material [0049-0050]. Therefore, where the expansion agents (CMC, MCC, or CCS) is mixed with the tobacco material, the expansion agent would clearly be located within the tobacco granule, within the broadest reasonable interpretation of the claim).
Regarding claim 7, Lampe makes obvious the tobacco granules comprising a core of expansion agent surrounded by tobacco material (Lampe states that its composition has a variety of different formats and configurations [0060], including core/shell arrangements [0071-0072], and wherein different layering and different compositions may have different cross-sections [0074]. This variety of different arrangements suggested by Lampe reasonably suggested a core of expansion agent surrounded by tobacco material, within the broadest reasonable interpretation of this limitation. For example, when there is a layered product formed with different formed compositions, the expansion agent in the composition in one cross-section (containing tobacco and one of the expansion agents) would be surrounded by the other composition similarly containing those aspects. Additionally, it may be considered that a granule containing the expansion agent and tobacco material would necessarily satisfy this relationship, as an innermost portion may be considered the “core” while an outer portion may be considered the tobacco material, as no further limiting characteristics are required of the “core” and surrounding material, such that any tobacco granule with both components would reasonably be considered to satisfy this limitation).
Regarding claim 8, Lampe makes obvious the tobacco granules formed by extrusion (Lampe states that ingredients may be processed by extrusion [0063], and the composition may be co-extruded [0074]).
Regarding claims 10 and 11, Lampe makes obvious the pH greater than 7 and from 8 to 9.5 (the tobacco product will usually have a pH from about 4 to 9 [0058]. As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
In the alternate, claims 4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Lampe (US2015/0230515A1), as applied to claim 1 above, and further in view of either Chen (WO2019223411A1, citing to English Equivalent US2021/0401030A1) or Li (US2017/0280769A1).
In the alternate regarding claims 4 and 7, it is well known in the art to situate tobacco granules to have an inner and outer components thereof (such as in a core/shell type arrangement), and it would have been obvious for a person of ordinary skill in the art to situate the composition of Lampe as such. Lampe does not limit the arrangement of its composition and states that it may be arranged in any format or configuration, including shape, form, size, etc., [0060]. Chen teaches a low-temperature smoking body (title) which is produced by extruding tobacco particles and which includes microcrystalline cellulose (MCC) [0081, 0102]. The device forms smoke without burning (aerosol) [0059]. Examples 3 and 12 are each examples wherein the center material is formed which comprises microcrystalline cellulose [0081, 0102]. To the outside of the center layer is formed a tobacco powder layer between the particle body and the shell [0026]. As such, Chen exemplifies the use of a center comprising a core of expansion agent (MCC) which is surrounded by tobacco material (tobacco powder layer). One of ordinary skill in the art would have found it obvious to modify the granule arrangement in Lampe to be as suggested in Chen, as Chen provides a known arrangement of having microcrystalline cellulose in the core surrounded by tobacco powder. One would have been motivated so as to ensure anti-leakage protection [0026], and so as to provide good uniformity [0082, 0102].
In the alternate, Li is for an electronic vaping device [title]. The material for use in the device may include tobacco material along with microcrystalline cellulose [0012]. Li teaches that the material may be encapsulated into a core and at least one shell layer structure [0008-0012], so as to configure the release in response to activation mechanisms such as heat and moisture [0008-0012]. One of ordinary skill in the art would have found it obvious to arrange the tobacco material and expanding agent of Lampe to be in a core/shell arrangement as suggested by Li. One would have been motivated as Li provides evidence that it is understood in the art that these types of structures allow for the release of the inner material in response to activation mechanisms such as moisture [0008-0012], which is the exact type of mechanism utilized in the instant application. And as there would be two possible arrangements (tobacco as the shell or tobacco as the core), it would have been obvious to try both of the arrangements and one would have reasonably landed upon the claimed relationship of having a core of expansion agent surrounded by tobacco material.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Qian (WO2020119011A1, citing to English Equivalent US2024/0225100A1).
Regarding claim 1, Qian teaches an aerosol-generating material (heating smoking set that does not burn. i.e., atomization [0002-0003, 0007]), comprising tobacco granules comprising tobacco material (the tobacco particles comprise tobacco powder [0007, 0054]), and an expansion agent (the granules comprise microcrystalline cellulose (MCC) [0007, 0054]. It is noted that the instant application lists this as a preferred example of the expansion agent [see pg. 4-5 of instant specification, claim 3].
Qian does not explicitly state that the components of MCC expand on contact with moisture to cause movement of the tobacco granules within the aerosol-generating material exposing further tobacco material. However, it is considered, the claimed property would implicitly be achieved, as "When the claimed and prior art products of identical or substantially identical in structure or composition, a prima facie case of obviousness has been established”, see MPEP 2112.01 I. And further, "Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present”, see MPEP 2112.01 II. In this case, Qian specifically contains tobacco granules, and may have any of the components of MCC wherein these components are art recognized (and identified in the instant application) to have an expanding effect on contact with moisture. Additionally, Qian specifies that CMC may have 8-20 parts by weight of microcrystalline cellulose [0007, 0054], such that the preferred weight range is satisfied (see Claim 2). And lastly, as the instant specification suggests that essentially any number of physical relations between the tobacco granules and expansion agent results in the claimed property (see claims 4-7 and 9, and pg. 5 of the instant specification, wherein the expansion agent may be arranged inside, outside, between, or throughout the tobacco granules), it is reasonably suggested by Qian that the tobacco composition thereof would have the expansion agent expanding on contact with moisture to cause movement of the tobacco granules and expose further tobacco material.
Regarding claim 2, Qian makes obvious 5% to 50% by weight of the expansion agent (as above, Qian preferably has 8-20 parts by weight of the microcrystalline cellulose [0007, 0054]. As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
Regarding claim 3, Qian makes obvious the expansion agent selected from the group consisting of CMC, MCC, and CCS (as in the rejection of claim 1 above, the composition may include components of microcrystalline cellulose (MCC) [0007]).
Regarding claim 4, Qian makes obvious the expansion agent is included within the tobacco granules (the tobacco particles comprise both the tobacco powder and microcrystalline cellulose [0007, 0054], such that the expansion agent would necessarily be within the tobacco granule).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Qian (WO2020119011A1, citing to English Equivalent US2024/0225100A1), as applied to claim 1 above, and further in view of either Chen (WO2019223411A1, citing to English Equivalent US2021/0401030A1) or Li (US2017/0280769A1).
Regarding claim 7, it is well known in the art to situate tobacco granules to have an inner and outer components thereof (such as in a core/shell type arrangement), and it would have been obvious for a person of ordinary skill in the art to situate the composition of Qian as such. QIAN does not limit the arrangement of its particles. Chen teaches a low-temperature smoking body (title) which is produced by extruding tobacco particles and which includes microcrystalline cellulose (MCC) [0081, 0102]. The device forms smoke without burning (aerosol) [0059]. Examples 3 and 12 are each examples wherein the center material is formed which comprises microcrystalline cellulose [0081, 0102]. To the outside of the center layer is formed a tobacco powder layer between the particle body and the shell [0026]. As such, Chen exemplifies the use of a center comprising a core of expansion agent (MCC) which is surrounded by tobacco material (tobacco powder layer). One of ordinary skill in the art would have found it obvious to modify the granule arrangement in Qian to be as suggested in Chen, as Chen provides a known arrangement of having microcrystalline cellulose in the core surrounded by tobacco powder. One would have been motivated so as to ensure anti-leakage protection [0026], and so as to provide good uniformity [0082, 0102].
In the alternate, Li is for an electronic vaping device [title]. The material for use in the device may include tobacco material along with microcrystalline cellulose [0012]. Li teaches that the material may be encapsulated into a core and at least one shell layer structure [0008-0012], so as to configure the release in response to activation mechanisms such as heat and moisture [0008-0012]. One of ordinary skill in the art would have found it obvious to arrange the tobacco material and expanding agent of Qian to be in a core/shell arrangement as suggested by Li. One would have been motivated as Li provides evidence that it is understood in the art that these types of structures allow for the release of the inner material in response to activation mechanisms such as moisture [0008-0012], which is the exact type of mechanism utilized in the instant application. And as there would be two possible arrangements (tobacco as the shell or tobacco as the core), it would have been obvious to try both of the arrangements and one would have reasonably landed upon the claimed relationship of having a core of expansion agent surrounded by tobacco material.
Claims 8, 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Qian (WO2020119011A1, citing to English Equivalent US2024/0225100A1), as applied to claim 1 above, and further in view of Franke (US2020/0163377A1).
Regarding claim 8, Qian does not explicitly say that its granules are formed by extrusion. However, extrusion is an extremely common way of forming granules for use in aerosolisable materials. Franke, for example, teaches aerosol forming agents for tobacco [0001-0004, 0096]. Extrusion is utilized on the composition thereof [0089-0091]. Forming the tobacco constituent by extrusion has the advantage of combining mixing, conditioning, homogenizing, and molding of the precursor composition [0090]. One of ordinary skill in the art would have found it obvious to form the granules through extrusion, as suggested by Franke, for the benefit of combining multiple steps into one as suggested by Franke [0090].
Regarding claims 10-11, Qian does not explicitly state what the pH of the tobacco material is. However, pH values of at least 7 and from 8-9.5 are extremely typical in the art. Franke, for example, suggests that the pH of the tobacco material is made to range from 7.5 to 10 [0046-0051]. As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). One of ordinary skill in the art would have found it obvious to modify the tobacco material of Qian so as to have a pH as suggested by Franke. One would have been motivated so as to provide the composition in a form where they are readily released from the releasing component and are readily transferred to the aerosol [0048].
Conclusion
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/T.F.S./Examiner, Art Unit 1749
/KATELYN W SMITH/Supervisory Patent Examiner, Art Unit 1749