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 Claims
Claims 1-2, and 4-17 are pending. Claims 1 and 16 are currently amended. Claims 18-19 are new.
Response to Amendment
The Response of 06/08/2026 is entered. The amendment to claim 16 overcomes the objection to claim 16, and thus the objection to claim 16 is withdrawn.
Claim Interpretation
Claim 1 requires a tobacco sheet for a heat-not-burn flavor inhaler, comprising tobacco powder. The tobacco powder is claimed as having a cumulative 90% particle size (D90) in a particle size distribution on a volume basis, measured by dry laser diffractometry, is greater than or equal to 200 µm (micron).
Neither claim 1, nor the present Specification define what D90 means. This is understood to be knowledge that is well understood by one of ordinary skill in the art. The Examiner is not familiar with the term, and thus has relied on a later published evidentiary reference to inform the understanding of the D90 limitation, which is further supported by a prior art reference from before the Application’s earliest effective filing date, Zero Instrument Just Measure It (evidentiary reference with a 2026 copyright) and Deforel et al. (WO 2020/074525 A1) (prior art).
Deforel discloses that in a D90 distribution, 90% if the particles by number are of a diameter less than or equal to the given D90 value and 10% of the particles by number are of a diameter measuring greater than the given D90 value, ([pg 5 lines 1-5]). While the prior art discloses this is by number of particles, this is considered equivalent to by volume, since a particular number of particles will always have a particular volume, assuming a well-mixed fraction of particles. This understanding is confirmed by the evidentiary reference, (pg 4 lines 5-6).
Thus, D90 is interpreted to require 90% of the particles to be sized less than the D90 value and 10% of the particles to be sized equal to or greater than the D90 value.
Claim 1 allows the D90 to be set an any value greater than or equal to 200 µm (micron). The present Specification suggests first that the upper range is not limited but in the same sentence provides an example that is less than or equal to 2000 µm (micron), ([0030]). Thus, while there is some evidence to suggest the D90 value has no upper limit, this Imitation is interpreted to have an upper value that one of ordinary skill in the art would reasonably expect could be workable for a tobacco particle size to be incorporated into a tobacco sheet, rather than a size that truly has no upper limit that could require further indefinite and scope of enablement analysis.
Thus, because the meaning and application of the D90 limitation is considered to be known to one of ordinary skill in the art, applied to mean a particle distribution where 90% of the particles are sized to be less than the D90 value and 10% of the particles are sized to be equal to or greater than the D90 value, and the upper bound of the D90 value is considered to be limited to a particle size distribution of particles that could be incorporated into a tobacco sheet with a reasonable expectation of success, the claim is considered definite and the scope enabled, and the claim is subject to this interpretation.
Response to Arguments
Applicant’s arguments, see Remarks pg 8 paragraphs 1-3, filed 06/08/2026, with respect to the rejection(s) of claim(s) 1-2 and 4-12 under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of certain disclosures of Jenkins (US 2024/0041090 A1) entitled to a priority date of 11/5/2020 based on GB 2017532.9.
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.
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.
Claim(s) 1, 2, 4-10, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jenkins (US 2024/0041090 A1) entitled to a priority date of 11/5/2020 based on (GB 2017532.9)(referred to as GB), Mastersizer 3000 Product Catalogue copyright 2019.
Regarding claim 1 and 18, Jenkins discloses:
An aerosol generating material comprising two composition, that are combined together to form the aerosol generating material, ([0004] corresponding to GB pg 1 lines 16-24), disclosing the aerosol generating material may be in the form of a sheet, ([0017] corresponding to GB pg 12 lines 11-18), considered a tobacco sheet because of the high percentage of tobacco, ([0046] corresponding to GB pg 8 lines 1-8), which is disclosed as being used with a noncombustible aerosol provision device, ([0010] corresponding to pg 2 lines 5-6, disclosing an aerosol generating article, considered to meet the limitation of a flavor inhaler, in which an aerosol generating substrate, such as a tobacco containing substrate, is heated rather than combusted), considered to meet the required heat not burn attribute and the requirement of flavor (tobacco) inhaler. Jenkins explicitly discloses an embodiment where the aerosol generating material is present in an amount of 75% by weight, ([0046] corresponding to GB pg 8 lines 6-8).
Jenkins further discloses that the tobacco material used in the composition to make the sheet may gave a defined D90 particle distribution where the D90 particle size may be selected from 100-800 microns, with some embodiments having a D90 particle distribution of up to 860 micrometers, and disclosing that the particle size distribution is a result effective variable where the smaller the particles sizes increase provide a good tensile strength, but smaller particles also result in a denser the aerosol generating material, and where higher density may decrease the fill value of the tobacco material, ([0031]-[0033] corresponding to GB pg 5 lines 10-30). Jenkins discloses that the D90 value may be established by sieve analysis, ([0027] corresponding to GB pg 5 line 17-18).
Mastersizer 3000 teaches that dry laser diffractometry is a known technique for measuring particle size distributions from 10 nm to 3.5 mm, which uses laser diffraction, (pg 4), with devices that support dry powder measurements, ([pg 8]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have modified Jenkins to provide a tobacco sheet for a heat-not-burn inhaler comprising tobacco powder of which a cumulative 90% particle size (D90) in a particle distribution on a volume bases is greater than 300 micrometers where a percentage of the tobacco powder contained in 100 mass% of the tobacco sheet ranges from 55-95 mass %. Jenkins explicitly discloses using a 75 mass % of tobacco in the aerosol generating material used to form the sheet, and discloses that the D90 particle size is a result effective parameter that affects the density of the sheet (fill value) and its tensile strength, and an overlapping range of D90 particle size distributions, with the claimed range that requires the D90 distribution be above 300 micrometers. It would have been obvious to select a D90 particle size distribution from above 300 micrometers to optimize the fill value variable against the tensile strength, as disclosed by Jenkins.
Although Jenkins discloses establishing the D90 particle size distribution based on sieve analysis, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to use the known technique of dry laser diffractometry taught by Mastersizer 3000, instead of using sieve analysis on the basis of simple substitution, MPEP 2143 B. Jenkins discloses or renders obvious all the limitations of claim 1, but does not disclose dry laser diffractometry. Mastersizer 3000 teaches that determining D90 using the technique of dry laser diffractometry was known. One of ordinary skill in the art could have substituted the known technique of determining the D90 particle size distribution dry laser diffractometry for sieve analysis to predictably establish the D90 particle size distribution of the tobacco used to make the sheet.
Regarding claim 2, modified Jenkins discloses the tobacco sheet according to claim 1. Jenkins further discloses that the tobacco material material may comprise, one or more of ground tobacco, tobacco fibre, cut tobacco, extruded tobacco, tobacco stem, tobacco lamina, reconstituted tobacco and/or tobacco extract, and where the tobacco material is a powder or may be ground. ([0023]-[0024] where tobacco stem and lamina is considered to read on tobacco leaf and midrib, corresponding to GB pg 4 lines 16-25).
Regarding claim 4-5, modified Jenkins discloses the tobacco sheet according to claim 1. Jenkins discloses the composition of the aerosol generating material used to form the sheet comprises an aerosol generator, referred to in Jenkins as an aerosol former, which is explicitly disclosed as glycerin, glycerol, or propylene glycol, in an embodiment, ([0019] corresponding to pg 3 lines 21-28).
Regarding claim 6, modified Jenkins discloses the tobacco sheet according to claim 4. Jenkins discloses the aerosol former (aerosol generator) may be present in some embodiments in an amount of about 15% by weight in the mixture used to make the sheet, ([0048] corresponding to GB pg 8 lines 25-27).
Regarding claim 7-9, modified Jenkins discloses the tobacco sheet according to claim 1. Jenkins discloses the composition of the aerosol generating material used to form the sheet comprises a forming agent (binder), ([0049] corresponding to pg 8 line29-30), and that in an embodiment the forming agent (binder) may be present in an amount of about 5%, ([0049] corresponding to GB pg 8-9 lines 36-2), where the binder may be an alginate, ([0021] corresponding to GB pg 4 lines 31-35), where alginates are known to be a polysaccharide.
Regarding claim 10, modified Jenkins discloses a heat not burn flavor inhaler comprising a tobacco segment including the tobacco sheet according to claim 1,([0129]-[0130] corresponding to GB pg 25 lines 1-7 Fig 2, where the aerosol generating material may comprise any of the aerosol generating materials disclosed by Jenkins including the tobacco sheet of claim 1).
Regarding claim 17, modified Jenkins discloses a heat not burn flavor inhaler of claim 10. Jenkins discloses the aerosol generating materials may be included in an aerosol generating article, ([0129]-[0130] corresponding to GB pg 25 lines 1-7 Fig 2, where the aerosol generating material may comprise any of the aerosol generating materials disclosed by Jenkins including the tobacco sheet of claim 1), and the articles are suitable with an aerosol generating device comprising a heating element, ([0134]-[0135] corresponding to GB pg 25 lines 19-22).
Regarding claim 19, modified Jenkins discloses the tobacco sheet according to claim 1. Jenkins discloses that the density of the sheet is a result effective variable based on particle size, and that density impacts the tensile strength of the sheet and the fill value in an inverse relationship, higher density gives greater tensile strength but worse fill value, lower density giving a lower tensile strength but a greater fill value, ([0031]-[0033] corresponding to GB pg 5 lines 10-30). Jenkins only specifies the D90 particle size distribution, with an explicit range of 100-800 micrometers, and a top size of 860 micrometers, ([0027], [0031]-[0033] corresponding to GB pg 5 lines 10-30), and leaves the selection of the D50 particle size distribution to one of ordinary skill in the art. Inherently D50 must have the following relationship to the overall particle size distribution: 0<D10≤D50≤D90. As stated in the rejection of claim 1, it would be obvious to one of ordinary skill in the art to select a D90 value of greater than 300 micrometers. This means that the range for D50, based on the disclosure of Jenkins, must be from greater than 0 micrometers to 300 micrometers, because that is the remaining range of values for D50 that is possible. This range of greater than 0 to 300 micrometers significantly overlaps the claimed range of greater than or equal to 40 micrometers to less than or equal to 1000 micrometers.
It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified Jenkins and used a D50 value from 40 up to below the D90 value taught by Jenkins (a maximum of 860 micrometers), because any of these values are compatible with the D90 particle size distributions disclosed, and would be expected to affect the density, tensile strength, and fill value of the sheet, where a D50 particle size distribution that is smaller will create a denser sheet, increasing tensile strength but decreasing fill value, and using a D50 particle size distribution that is larger will cause a reduction in sheet density, decreasing tensile strength but increasing fill value.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jenkins (US 2024/0041090 A1) entitled to a priority date of 11/5/2020 based on (GB 2017532.9)(referred to as GB), Mastersizer 3000 Product Catalogue copyright 2019, as applied to claim 10, and in further view of Deforel et al. (WO 2020/074535 A1)
Regarding claim 11, modified Jenkins discloses the heat not burn flavor inhaler of claim 10. Jenkins further discloses that a consumable is an article comprising aerosol generating material and may comprise one or more other components such as an aerosol generating material storage area, an aerosol generating material transfer component, an aerosol generating area, a housing, a wrapper, a mouthpiece, a filter, and/or an aerosol modifying agent where in some embodiments the consumable is in a rod shape, ([0111] corresponding to GB pg 22 lines 9-19), where the consumable is for use with a non-combustible aerosol provision device, ([0129] Fig 2, corresponding to GB pg 25 lines 1-3 Fig 2). Jenkins does not disclose that the tobacco containing segment includes a first segment and a second segment, and the mouthpiece segment includes a cooling segment with the disclosed filter.
Deforel teaches a multi-segment a heat not burn flavor inhaler, ([pg 23-24 lines 28-11] Fig 4a-b), and is thus considered within the inventor’s field of endeavor. Deforel teaches the flavor inhaler comprises a mouthpiece segment, the tobacco containing segment comprises two segments, where one segment contains the tobacco sheet according to claim 1, and another segment contains cloves and an aerosol generator, and the mouthpiece segment includes a cooling segment and a filter segment, ([pg 23-24 lines 28-11] Fig 4a-b).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified Jenkins according to the teachings of Deforel. Starting with the tobacco segment of modified Jenkins, one of ordinary skill in the art would have found it obvious to use the mouthpiece segment, and clove containing segment, and cooling segment, arranged according to the teachings of Deforel, to provide a kreteck style cigarette which is popular with certain poplulations, (Deforel [pg 1 lines 27-28]). This is considered the combination of prior art elements according to known methods to yield predictable results, MPEP 2143 I. A. Here the references disclose or teach every claimed element. One of ordinary skill in the art could have combined the elements as claimed by known methods, and in such a combination, each element merely performs the same function as it does separately. One of ordinary skill in the art would have recognized the results of the combination would have predictable produced a kreteck style cigarette for use with a non-combustible aerosol generating device.
Regarding claim 12, modified Jenkins discloses the heat not burn flavor inhaler of claim 11.
Deforel teaches the flavor inhaler comprises a mouthpiece segment, the tobacco containing segment comprises two segments, where the first segment contains cloves and an aerosol generator, the first downstream plug, ([pg 23-24 lines 28-11] Fig 4a-b), where plug is understood to include the sheet of primarily clove particles (considered to include plant fiber) gathered transversely and circumscribed with a wrapper, ([pg 11 lines 2-4]).
Claim(s) 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jenkins (US 2024/0041090 A1) entitled to a priority date of 11/5/2020 based on (GB 2017532.9)(referred to as GB), Mastersizer 3000 Product Catalogue copyright 2019, as applied to claim 10, and in further view of Deforel et al. (WO 2020/074535 A1) and SEO et al. (US 2021/0000168 A1).
Regarding claim 13, modified Jenkins discloses the heat not burn flavor inhaler of claim 10.
Jenkins discloses an article for use with an non-combustible aerosol provision device, where the consumable may further comprise a wrapper, a filter, a mouthpiece and other components, ([0111] corresponding to GB pg 24 lines 23-27). Jenkins discloses tha the mouthpiece segment may comprise a body of material such as a fibrous or filamentary tow, ([0132] corresponding to GB pg 25 lines 13-15). Jenkins does not disclose the fiber circumferential cross section has a Y-shape, or the range of values that a single fiber denier may be equal to or within the range of 8-12.
Deforel discloses a heat not burn flavor inhaler of claim 10. Deforel discloses that the aerosol generating article may comprise a rod, where the rod comprises the substrate of the invention in one or more plugs, and may optionally include one or more filter segments, ([pg 13 lines 5-8]). Deforel discloses that the article may comprise a mouthpiece downstream of the aerosol generating substrate, and other filter segments including a hollow acetate tube, spaces, or aerosol cooling element, ([pg 17 lines 18-19]), and the filter may comprise one or more filtration materials including cellulose acetate tow, ([pg 17 lines 20-24]). Deforel does not disclose the fiber circumferential cross section has a Y-shape, or the range of values that a single fiber denier may be equal to or within the range of 8-12.
Seo teaches a tobacco rod including an aerosol generating substrate wrapped with a wrapper and a filter through which aerosol generated from the aerosol generating substrate passes, ([0012]), and is thus within the inventor’s field of endeavor. Seo teaches the filter may include cellulose acetate tow having a Y-shaped cross sectional area, ([0017]), and the filter may include a cellulose acetate tow having a mono denier in the range of 10-12, ([0019]), may have a mono denier of 11.7, ([0020]), and may have a mono denier of 9, ([0021]). SEO teaches that the second segment of the filter may be made of cellulose acetate having a preferred mono denier in the range of 8-10, where the cross section of the filament is Y-shaped, ([0083]Fig 5 ref 322). SEO teaches that using a tow with a Y-shaped cross section, there is an advantage in that the harmful substances such as tar coming out of the filter may be minimized, ([0097]).
It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified Jenkins according to the techniques taught by SEO. This is the use of a known technique to improve a similar product in the same way. MPEP 2143 I. Examples of Rationales (C). The modified Jenkins reference teaches a base product upon which the claimed invention, further requires the fiber to have a Y-shaped cross section and mono denier value equal to or within the range of 8-12 can be seen as an improvement. Seo teaches a comparable product that while not the same as the base product, has been improved with a filter comprising fibers having a Y-shaped cross section and having a preferred mono denier value of 8-10. One of ordinary skill in the art could have applied the known improvement technique in the same way to the base product, and the results would have been predictable to one of ordinary skill in the art. One of ordinary skill in the art would have been further motivated to apply this technique, because Seo teaches that tow with a Y-Shaped cross sectional area improves tar filtration from the aerosol passing through the filter.
Regarding claim 14, modified Jenkins discloses a heat not burn flavor inhaler of claim 13. Neither Jenkins nor Deforel disclose or teach the density of the filter element is a value equal to or within values comprising the range of 0.09 – 0.14 g/cm3.
Seo teaches a filter comprising a fiber with a y-shaped cross-sectional area, having a mono denier value of 9, with a length of 96 mm, a mass of 395 mg, and a circumference of 21.99, table 5 first row, ([0101]). The formula for the volume of a cylinder is considered to be well known and is V = pi * h * R2. Where V = volume, pi is a constant that may be provided as 3.14, h is height or length and R is radius of the cross section of the cylinder. The formula for the circumference of a circle is considered to be well known, and is C = 2 * pi * R. By describing the filter as having a circumference of 21.99mm, Seo is teaching the radius of the filter is 3.50 mm. By teaching the filter has a length of 96 mm, Seo is further teaching that the volume of the filter is 3696 mm3. The density of an object is well known to be its mass divided by its volume, D = m / V. The mass of the filter divided by its volume disclosed by Seo is 0.107 mg/mm3, which converts to 0.107 g/cm3. Thus, Seo teaches using a filter element having a density within the claimed range.
Regarding claim 15, modified Jenkins discloses a heat not burn flavor inhaler of claim 10. Jenkins discloses that the components of the consumable may be wrapped by a wrapper, ([0133] corresponding to pg 25 lines 16-17).
Deforel discloses that the aerosol generating article may comprise a rod, where the rod comprises the substrate of the invention in one or more plugs, and may optionally include one or more filter segments, ([pg 13 lines 5-8]). Deforel discloses that the article may comprise a mouthpiece downstream of the aerosol generating substrate, and other filter segments including a hollow acetate tube, spaces, or aerosol cooling element, ([pg 17 lines 18-19]), and the filter may comprise one or more filtration materials including cellulose acetate tow, ([pg 17 lines 20-24]). Deforel discloses that the segments may be arranged sequentially to form an aerosol generating article, and wrapped by a cigarette paper, ([pg 22 lines 24-25]), see also Fig 4a with a tobacco containing segment 4020a, a cooling segment, a hollow cellulose acetate tube 1030, a space element 1040, and a mouthpiece filter 1050 wrapped by a cigarette wrapping paper 1060, where the reference number descriptions are provided, ([pg 22 lines 22-23]). The wrapping material is not disclosed as having a high heat transfer portion having higher heat conductivity than a wrapper member with which the wrapper contacts, where the high heat transfer portion wraps an aera near a downstream end of the tobacco containing segment.
Seo teaches a tobacco rod including an aerosol generating substrate wrapped with a wrapper and a filter through which aerosol generated from the aerosol generating substrate passes, ([0012]), and is thus within the inventor’s field of endeavor. Seo teaches the tobacco rod may be surrounded by a heat conducting material that may be, but is not limited to a metal foil such as aluminum foil, which may improve a thermal conductivity applied to the tobacco rod by evenly dispersing the heat transferred to the tobacco rod, an thus improving tobacco taste, ([0066]). Seo discloses that the cigarette may be wrapped by at least one wrapper, ([0075]), reasonably disclosing articles wrapped with one wrapper. Seo discloses a wrapper may be a metal foil aluminum foil bonded to a general filter wrapping paper, ([0077]).
It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have improved the heat not burn flavor inhaler with the wrapper of Seo comprising a metal foil bonded to a general filter wrapping paper. This is the simple substitution of one known element for another to obtain predictable results, MPEP 2143 I. (B). Modified Jenkins discloses a product which differs from the claimed device by the substitution of a wrapping paper with improved heat transfer portion compared to a wrapped member with which the wrapping paper contacts, and where the high heat transfer portion wraps an area near a downstream end of the tobacco containing segment. Seo discloses a wrapper comprising a metal foil bonded to a general filter wrapping paper, and a technique of wrapping the article with one wrapper, further disclosing the metal foil improves heat distribution to the tobacco rod. One of ordinary skill in the art could have substituted the general cigarette wrapping paper in modified Jenkins for the foil backed cigarette paper of Seo, to obtain a wrapped cigarette where the tobacco portion predictably had improved heat transfer throughout the surfaces of the tobacco portion.
Regarding claim 16, modified Jenkins discloses a heat not burn flavor inhaler of claim 15.
Because Seo teaches that the article may be wrapped by a single wrapper, and teaches that the wrapper may be a metal backed foil, the heat transfer portion would roll to wrap the entire article, meeting the narrower limitation requiring the high heat transfer portion to wrap an aera near the downstream end of the tobacco containing segment to an aera near an upstream end of the adjacent member.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 4-6, 10 and 17 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, and 4-7 of copending Application No. 18591667 (reference application, claim set of 03/21/2024). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1, 18591667 discloses: A tobacco sheet for a heat-not-burn flavor inhaler, comprising tobacco powder of which a cumulative 90% particle size (D90) in a particle size distribution on a volume basis, measured by dry laser diffractometry, is greater than or equal to 200 µm, claim 1.
The claimed D90 particle size distribution greater than 300 µm, overlaps the claimed range in the reference application, rendering it obvious. The percentage of tobacco powder in the tobacco sheet is not claimed, but some percentage of the sheet must be tobacco. To interpret the limitation requiring the inclusion of tobacco powder, one of ordinary skill in the art would look to the reference application for guidance and find that 55-90% is preferred, ([0016]), rendering the claim obvious.
Regarding claim 4, 18591667 discloses: The tobacco sheet for a heat-not-burn flavor inhaler according to claim 1, further comprising an aerosol generator, required by claim 1.
Regarding claim 5, 18591667 discloses: The tobacco sheet for a heat-not-burn flavor inhaler according to claim 4, wherein the aerosol generator is at least one selected from the group consisting of glycerin, propylene glycol, and 1,3-butanediol, met by claim 5.
Regarding claim 6, 18591667 discloses: The tobacco sheet for a heat-not-burn flavor inhaler according to claim 4, wherein a percentage of the aerosol generator contained in 100mass% of the tobacco sheet ranges from 4mass% to 50mass%, overlapped by the range in claim 4.
Regarding claim 10, 18591667 discloses: A heat-not-burn flavor inhaler comprising a tobacco-containing segment including the tobacco sheet for a heat-not-burn flavor inhaler according to claim 1, met by claim 6.
Regarding claim 17, 18591667 discloses: A heat-not-burn flavor inhaling system comprising: the heat-not-burn flavor inhaler according to claim 10; and a heating device that heats the tobacco-containing segment, met by claim 7.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 10, and 17-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9 of copending Application No. 18493443 (reference application claims filed 03/29/2024). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1, 18493443 discloses: A tobacco sheet for a heat-not-burn flavor inhaler, comprising tobacco powder of which a cumulative 90% particle size (D90) in a particle size distribution on a volume basis, measured by dry laser diffractometry, is greater than or equal to 300 µm, claim 12.
The percentage of tobacco powder in the tobacco sheet is not claimed, but some percentage of the sheet must be tobacco. To interpret the limitation requiring the inclusion of tobacco powder, one of ordinary skill in the art would look to the reference application for guidance and find that 55-90% is preferred, ([0015]), rendering the claim obvious.
Regarding claim 10, 18493443 discloses: A heat-not-burn flavor inhaler comprising a tobacco-containing segment including the tobacco sheet for a heat-not-burn flavor inhaler according to claim 1, claim 8.
Regarding claim 17, 18493443 discloses: A heat-not-burn flavor inhaling system comprising: the heat-not-burn flavor inhaler according to claim 10; and a heating device that heats the tobacco-containing segment, claim 9.
Regarding claim 18, 19162416 discloses: The tobacco sheet for a heat-not-burn flavor inhaler according to claim 1, wherein the cumulative particle size distribution on a volume basis, measured by dry laser diffractometry, is greater than 200 micrometers and less than 2000 micrometers, claim 13, overlapping the claimed range and rendering it obvious.
Regarding claim 19, 19162416 discloses: The tobacco sheet for a heat-not-burn flavor inhaler according to claim 1, wherein the tobacco powder has a 50% cumulative particle size (D50) of greater than or equal to 40 micrometers to less than or equal to 1,000 micrometers, claim 14.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1-10 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-12 of copending Application No. 19162416 (reference application claims filed 09/05/2025). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1, 19162416 discloses: A tobacco sheet for a heat-not-burn flavor inhaler, comprising tobacco powder of which a cumulative 90% particle size (D90) in a particle size distribution on a volume basis, measured by dry laser diffractometry, is greater than or equal to 200 µm, claim 11, rendering obvious the selection of a D90 particle size distribution within that range (such as the claimed range of over 300 µm).
Claim 3 discloses that the sheet comprises a powder of at sheet of tobacco raw material selected from a group consisting of tobacco parts, and claim 4 discloses that the powder is contained in a portion of 45-95% by mass of the tobacco sheet, overlapping the claimed range and rendering it obvious..
Regarding claim 2, 19162416 discloses: The tobacco sheet for a heat-not-burn flavor inhaler according to claim 1, wherein the tobacco powder is at least one tobacco raw material selected from the group consisting of leaf tobacco, leaf midrib, and stalk, claim 3.
Regarding claim 3, 19162416 discloses: The tobacco sheet for a heat-not-burn flavor inhaler according to claim 1, wherein a percentage of the tobacco powder contained in 100mass% of the tobacco sheet ranges from 45mass% to 95mass%, claim 4.
Regarding claim 4, 19162416 discloses: The tobacco sheet for a heat-not-burn flavor inhaler according to claim 1, further comprising an aerosol generator, claim 5.
Regarding claim 5, 19162416 discloses: The tobacco sheet for a heat-not-burn flavor inhaler according to claim 4, wherein the aerosol generator is at least one selected from the group consisting of glycerin, propylene glycol, and 1,3-butanediol, claim 6.
Regarding claim 6, 19162416 discloses: The tobacco sheet for a heat-not-burn flavor inhaler according to claim 4, wherein a percentage of the aerosol generator contained in 100mass% of the tobacco sheet ranges from 4mass% to 50mass%, claim 7.
Regarding claim 7, 19162416 discloses: The tobacco sheet for a heat-not-burn flavor inhaler according to claim 1, further comprising a forming agent, claim 8.
Regarding claim 8, 19162416 discloses: The tobacco sheet for a heat-not-burn flavor inhaler according to claim 7, wherein the forming agent is at least one selected from the group consisting of polysaccharide, protein, and synthetic polymer, claim 9.
Regarding claim 9, 19162416 discloses: The tobacco sheet for a heat-not-burn flavor inhaler according to claim 7, wherein a percentage of the forming agent contained in 100mass% of the tobacco sheet ranges from 0.1 mass% to 15mass%, claim 10.
Regarding claim 10, 19162416 discloses: A heat-not-burn flavor inhaler comprising a tobacco-containing segment including the tobacco sheet for a heat-not-burn flavor inhaler according to claim 1, claim 12.
Regarding claim 17, 19162416 discloses: A heat-not-burn flavor inhaling system comprising: the heat-not-burn flavor inhaler according to claim 10; and a heating device that heats the tobacco-containing segment, claim 13.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL E VAKILI whose telephone number is (571)272-5171. The examiner can normally be reached Monday - Friday 7:30 am - 4:30 pm.
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/D.E.V./Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747
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