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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/04/2025 has been entered.
Status of the Claims
Claims 1-13, 15, and 18-19 are pending and are subject to this Office Action.
Claims 11-13 are withdrawn.
Claims 1-2, 5-8, 15, and 18 are amended.
Claims 16-17 are cancelled.
Claim 19 is newly added.
Response to Amendment
The Examiner acknowledges Applicant’s response filed on 11/04/2025 containing
amendments and remarks to the claims.
Response to Arguments
Applicant’s arguments, see page 5, filed 11/04/2025, with respect to the rejection of claims 5-8 and 15 under 35 USC 112(b) have been fully considered and are persuasive. The rejection of claims 5-8 and 15 under 35 USC 112(b) has been withdrawn.
Applicant’s arguments, see page 5, filed 11/04/2025, with respect to the rejection(s) of claim(s) 1 under 35 USC 103 have been fully considered and are persuasive. The Applicant has amended claim 1 to require that the refined plant fibers are fibrillated, whereas previously this was not required. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of previously applied art and newly found art.
In specific regards to the Applicant's arguments on page 6, filed 11/04/2025, they have been fully considered but they are not persuasive. The Applicant argues that Abi’s disclosure relates to reconstituted material obtained by casting or laminating, as opposed to papermaking, as Abi’s product is obtained by depositing an amorphous solid of binder composition, not by forming a fibrous web. The Examiner does not find this to be persuasive because the claim recites wherein the two fibrous supports are produced by a papermaking process, not the plant extract composition, and therefore the disclosure of how the amorphous solid is made is not relevant to the claim limitation directed to the two fibrous supports.
The Applicant further argues that Abi’s reference to a “Fourdrinier-based papermaking-type approach” references the formation of a reconstituted tobacco material within the amorphous solid, and does not disclose, suggest, or imply that the claimed fibrous supports are formed by papermaking. The Examiner does not find this to be persuasive because Abi explicitly teaches that reconstituted tobacco material may be formed by a Fourdrinier-based paper making-type approach (page 42, third paragraph) and as such it would be obvious to one of ordinary skill in the art that this may apply to the carrier sheet of reconstituted tobacco, as this is merely a known way to produce reconstituted tobacco.
On page 7, the Applicant further argues that Example 2 of the application provides direct comparative data demonstrating an unexpected and advantageous effect of the claimed invention. The Examiner does not find this to be persuasive because Example 2 compares the sheets of Example 1.1 and Comparative Example 1, where Example 1.1 has a greater amount of total content of solid of the plant extract (Sp) compared to Comparative Example 1 (37.1 % vs 29.4%). The Applicant has admitted that Sp affects the organoleptic properties and therapeutic properties of the aerosol formed (see [0048] of the spec), and therefore it would appear that this difference in the amount of solid plant extract plays a role in taste perception and is not necessarily just the density of the sheet that affects taste perception. Further, the Applicant still needs to (1) compare the claimed invention to the closest prior art which is commensurate in scope with the claims (see MPEP 716.02.b.III) and (2) show that the unexpected results occur over the entire claimed range (see MPEP 716.02.d). The Applicant points to Example 2 for unexpected results but does not analyze Abi/Gellatly to the comparative example. Moreover, Applicant only has one data point (0.71 g/cm3) whereas the claimed range is much broader at “greater than or equal to 0.60 g/cm3” and would need more data points to show unexpected results over this entire range.
On pages 7-9, the Applicant further argues that the intended use rationale from MPEP § 2144.07 relates to the selection of a known material for its intended use, as opposed to the property of a material. The Examiner finds this to be persuasive. However, MPEP 2144.05.II.A teaches 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. Therefore as Abi is silent to the material property of density of the reconstituted tobacco sheet, it would be obvious for one of ordinary skill in the art to be motivated to look to other known teachings of reconstituted tobacco sheets that one could apply with a reasonable expectation of success in the reconstituted tobacco sheet having a suitable density. Further, Abi teaches the amorphous solid having an area density between 30 g/m2 and 120 g/m2 (page 31, last paragraph) and a thickness of about 0.015 mm to about 1 mm (page 26, second paragraph), and as such the amorphous solid has a density between 0.03 g/cm3 and 8 g/m3. As all three laminate layers have a density that overlaps the claimed range of greater than or equal to 0.60 g/cm3, then the laminate as a whole would also have a density that overlaps the claimed range of greater than or equal to 0.60 g/cm3 and is therefore prima facie obvious.
The following is a modified rejection made based on amendments made to the claims.
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.
Claim(s) 1-9, 15, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abi (WO2020/025730), Gellatly (US 5,724,998) and Hanada (US2022/0071275).
Regarding claims 1-3 and 19, Abi teaches:
A tubular substrate that may be an amorphous solid sheet which has been rolled to form a tube…the substrate may comprise…a carrier on which the amorphous solid is provided…such as a sheet of reconstituted tobacco (page 7, third paragraph). The amorphous solid sheet defines a reconstituted plant sheet.
The amorphous solid may be included as a sheet (which may be part of the tubular substrate). In one embodiment, the sheet forms part of a laminate material with a layer (preferably comprising paper) attached to a top and bottom surface of the sheet (page 35, fourth and fifth paragraphs). The layers attached to a top and bottom surface of the sheet define two fibrous supports.
The amorphous solid typically comprises an active substance such as nicotine and/or a tobacco extract (pages 3-4, last paragraph). Therefore the amorphous solid reads on a plant extract composition between the two fibrous supports.
The amorphous solid may contain aerosol generating agents (pages 3-4, last paragraph).
The amorphous solid having an area density between 30 g/m2 and 120 g/m2 (page 31, last paragraph) and a thickness of about 0.015 mm to about 1 mm (page 26, second paragraph). As such the amorphous solid has a density between 0.03 g/cm3 and 8 g/cm3.
Abi does not appear to explicitly disclose (I) the two fibrous supports comprising refined plant fibers and a plant extract and how the two fibrous supports are produced, (II) the density of the reconstituted plant sheet, and (III) wherein the refined plant fibers are fibrillated.
In regard to (I), Abi further teaches:
It may be preferable that a surface of the carrier sheet abutting the amorphous solid be formed from a porous material such as paper or reconstituted tobacco. This allows for a strong bond to form between the amorphous solid and porous carrier surface (page 8, first paragraph).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify the layers attached to the top and bottom surface of the sheet to be formed from reconstituted tobacco as taught by Abi, because Abi teaches this allows a strong bond to form between the amorphous solid and carrier surface, and this merely involves substituting one known type of carrier sheet for another with a reasonable expectation of success in forming a laminate reconstituted plant sheet. The two fibrous supports being a sheet of reconstituted tobacco reads on wherein the plant fibers are tobacco fibers as recited in claim 3.
Abi further teaches:
The reconstituted tobacco material may comprise tobacco fibers, and may be formed by casting, a Fourdrinier-based paper making-type approach with back addition of tobacco extract (page 42, second paragraph).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make to the carrier sheet of reconstituted tobacco formed by a Fourdrinier-based paper making-type approach with back addition of tobacco extract as taught by Abi, as the carrier sheet of Abi is reconstituted tobacco, and this is merely a known way to produce reconstituted tobacco. The sheet of reconstituted tobacco defines a fibrous support comprising refined plant fibers (i.e. tobacco fibers) and a plant extract (i.e. tobacco extract), and produced by a papermaking process (i.e. Fourdrinier-based paper making-type approach).
In regard to (II), Gellatly, directed to reconstituted tobacco sheets, teaches:
A reconstituted tobacco sheet with a sheet density of 0.98 g/cm3 (Col. 13-14, example 4).
As Abi is silent to the material property of density of the reconstituted tobacco sheet, it would be obvious for one of ordinary skill in the art to be motivated to look to other known teachings of reconstituted tobacco sheets that one could apply with a reasonable expectation of success in the reconstituted tobacco sheet having a suitable density. Therefore it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make to the fibrous supports of Abi have a density of 0.98 g/cm3 as taught by Gellatly, as both Abi and Gellatly are directed to reconstituted tobacco sheets, and this merely involves discovering the optimum or workable ranges by routine experimentation.
As the amorphous solid has a density of between 0.03 g/cm3 and 8 g/m3 which overlaps the claimed range, and the reconstituted tobacco sheets have a density of 0.98 g/cm3 that falls within the claimed range, then the laminate as a whole would also have a density that overlaps the claim 1 range of greater than or equal to 0.60 g/cm3 and the claim 2 range of between 0.62 g/cm3 and 1.50 g/cm3, and the claim 19 range of between 0.70 g/cm3 and 1 g/cm3 and is therefore prima facie obvious.
In regard to (III) Abi does not appear to explicitly disclose wherein the refined plant fibers are fibrillated.
Hanada, directed to a tobacco sheet, teaches:
A refiner that cuts the fine pieces of leaf tobacco into even shorter fibers and gives these fibers a fluffy texture (fibrillation) so they can be easily coupled with one another [0038].
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to make the plant fibers of Abi be fibrillated as taught by Hanada, because both Abi and Hanada are directed to sheets of material comprising tobacco fibers, Hanada teaches fibrillation allows the fibers to easily couple with one another, and this merely involves incorporating a known type of tobacco fiber (i.e. fibrillated) to a similar material comprising tobacco fibers to yield predictable results.
Regarding claim 4, Abi further teaches:
Aerosol-forming materials described herein may, in some cases, comprise an amorphous solid in an amount from 70 wt.% to about 90 wt.% (page 3, first paragraph under Detailed Description).
The amorphous solid may comprise 20 to 35 wt.% of an aerosol generating agent on a dry weight basis (page 28, first paragraph). As the amorphous solid is 70 to 90% of the aerosol-forming material, the aerosol generating agent is therefore 14 to 31.5 wt.% of the reconstituted plant sheet.
The Applicant’s specification teaches that the total content by weight of solids is calculated using the dry weight of the sample (see [0050]-[0052]). Therefore dry weight basis is considered to be equivalent to total content by weight of solids.
The range of 14 to 31.5 % taught by the prior art overlaps the claimed range of between 10% and 30% and therefore establishes a prima facie case of obviousness.
Regarding claim 5, Abi further teaches:
Aerosol-forming materials described herein may, in some cases, comprise an amorphous solid in an amount from 70 wt.% to about 90 wt.% (page 3, first paragraph under Detailed Description).
The amorphous solid may comprise 5-60 wt.% (calculated on a dry weight basis) of tobacco extract (page 29, first paragraph). The Applicant’s specification teaches that the total content by weight of solids is calculated using the dry weight of the sample (see [0050]-[0052]). Therefore dry weight basis is considered to be equivalent to total content by weight of solids.
As the amorphous solid is 70 to 90% of the aerosol-forming material, the tobacco extract of the plant extract composition is therefore 3.5 to 54 wt.% of the reconstituted plant sheet. Abi is silent to the amount of tobacco extract in the remainder of the aerosol-forming material. However, the remainder comprising 0% tobacco extract would maintain the 3.5 to 54 wt.% of the reconstituted plant sheet, which overlaps the claimed range of between 30% and 60%, and if the remainder comprises 100% of tobacco extract, this would result in the total tobacco extract in the reconstituted plant sheet being between 14.5 and 72 wt.%, which overlaps the claimed range of between 30% and 60%. As such, no matter the amount of tobacco extract in the remainder of the aerosol-forming material, the prior art teaches a range that overlaps the claimed range of between 30% and 60% and therefore establishes a prima facie case of obviousness.
Regarding claim 6, Abi further teaches:
Aerosol-forming materials described herein may, in some cases, comprise an amorphous solid in an amount from 70 wt.% to about 90 wt.% (page 3, first paragraph under Detailed Description).
The amorphous solid may comprise 20 to 35 wt.% of an aerosol generating agent on a dry weight basis (page 28, first paragraph). As the amorphous solid is 70 to 90% of the aerosol-forming material, the aerosol generating agent is therefore 14 to 31.5 wt.% of the reconstituted plant sheet.
The amorphous solid may comprise 5-60 wt.% (calculated on a dry weight basis) of tobacco extract (page 29, first paragraph). As the amorphous solid is 70 to 90% of the aerosol-forming material, the tobacco extract is therefore 3.5 to 54 wt.% of the reconstituted plant sheet. This yields the sum of the aerosol generating agent and the tobacco extract on a dry weight basis to be between 17.5 and 85.5 wt.%.
The Applicant’s specification teaches that the total content by weight of solids is calculated using the dry weight of the sample (see [0050]-[0052]). Therefore dry weight basis is considered to be equivalent to total content by weight of solids.
Abi is silent to the amount of tobacco extract and aerosol-generating agent in the remainder of the aerosol-forming material. However, the remainder comprising 0% tobacco extract and aerosol-generating agent would maintain the 17.5 and 85.5 wt.%. of the reconstituted plant sheet, which overlaps the claimed range of between 40% and 80%, and if the remainder comprises 100% of tobacco extract and/or aerosol-generating agent, this would result in the total tobacco extract and aerosol generating agent in the reconstituted plant sheet being between 25.75 and 89.85 wt.%, which overlaps the claimed range of between 40% and 80%. As such, no matter the amount of tobacco extract and aerosol-generating agent in the remainder of the aerosol-forming material, the prior art teaches a range that overlaps the claimed range of between 40% and 80% and therefore establishes a prima facie case of obviousness.
Regarding claim 7, Abi further teaches:
In some cases the amorphous solid is deposed between about 0.1 to 0.5 mm from the heater. These minimum distances may reflect the thickness of a carrier that supports the amorphous solid (pages 10-11, last paragraph).
The amorphous solid may have a thickness between 0.015 mm and 1 mm (page 26, second paragraph).
The sum of the thickness of the amorphous solid (i.e. plant extract composition) and the carrier (i.e. fibrous supports) therefore defines the thickness of the reconstituted sheet.
The range of between 115 um (0.115 mm) and 1500 um (1.5 mm) taught by the prior art overlaps the claimed range of between 250 um and 1050 um and therefore establishes a prima facie case of obviousness.
Regarding claim 8, Abi further teaches:
In some cases the amorphous solid is deposed between about 0.1 to 0.5 mm from the heater. These minimum distances may reflect the thickness of a carrier that supports the amorphous solid (pages 10-11, last paragraph).
The amorphous solid may have a thickness between 0.015 mm and 1 mm (page 26, second paragraph).
The basis weight of the reconstituted plant sheet is calculated by multiplying its density by its thickness (see [0015] of the Applicant’s specification). As such, the basis weight of the amorphous solid is between 0.45 g/m2 and 8,000 g/m2, and the basis weight of the fibrous supports is between 98 g/m2 and 490 g/m2. As the basis weight of each layer overlaps the claimed range of greater than 200 g/m2, then the laminate as a whole would also have a basis weight that overlaps the claimed range and is therefore prima facie obvious.
Regarding claim 9, Abi further teaches wherein the aerosol generating agent is chosen from sorbitol, glycerol, propylene glycol, and erythritol (page 28, first paragraph).
Regarding claim 15, Abi further teaches wherein the refined plant fibers and the plant extract of the fibrous supports, and the plant extract composition are from tobacco plants (page 42, second paragraph). Abi does not appear to disclose wherein the refined plant fibers and the plant extract are chosen from medicinal plants.
However, Abi further teaches:
The active substance may comprise or be derived from one or more botanicals or constituents, derivatives or extracts thereof. The material may be in the form of liquid, gas, solid, powder, dust, crushed particles, granules, pellets, shreds, strips, sheets, or the like. Example botanicals are tobacco and eucalyptus (page 39, first full paragraph).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify the fibrous supports and the plant extract composition of Abi to be comprised from eucalyptus instead of tobacco, as Abi teaches eucalyptus and tobacco are both botanical materials suitable for use in a smoking article, and the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination. See MPEP § 2144.07.
The Applicant’s specification teaches that eucalyptus is a medicinal plant (see [0073] of the specification) and therefore having the fibrous supports and the plant extract composition be from eucalyptus would yield the refined plant fibers and the plant extract being chosen from medicinal plants.
Regarding claim 18, Abi further teaches:
In some cases the amorphous solid is deposed between about 0.1 to 0.5 mm from the heater. These minimum distances may reflect the thickness of a carrier that supports the amorphous solid (pages 10-11, last paragraph).
The basis weight of the reconstituted plant sheet is calculated by multiplying its density by its thickness (see [0015] of the Applicant’s specification). As such, the basis weight of the fibrous supports is between 98 g/m2 and 490 g/m2 which overlaps the claimed range of between 60 g/m2 and 200 g/m2 and is therefore prima facie obvious.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abi (WO2020/025730), Gellatly (US 5,724,998), and Hanada (US2022/0071275) as applied to claim 1 above, and further in view of Hernandez (US2018/0014568).
Regarding claim 10, Abi does not appear to explicitly disclose the reconstituted plant sheet having been calendared.
Hernandez, directed to a tobacco composite, teaches:
A nonwoven tobacco containing fabric (i.e. tobacco sheet) that is manufactured by taking a staple material made from small fibers, which are combined to form a net or web that can be bound in a number of ways ([0059]).
Hot calendaring is a thermal bonding technique used to bond or stabilize a web structure ([0073]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify the reconstituted plant sheet of Abi to have been hot calendared as taught by Hernandez, because both Abi and Hernandez are directed to plant sheets, Hernandez teaches hot calendaring bonds or stabilizes the web structure, and this merely involves incorporating a known way to bond a plant sheet (i.e. hot calendaring) to a similar plant sheet to yield predicable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicole A Szumigalski whose telephone number is (703)756-1212. The examiner can normally be reached Monday - Friday: 8:00 - 4:30 EST.
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/N.A.S./Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755