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 .
Claim Rejections - 35 USC § 102
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 1-4, 10, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Strickland (US 20050244521 A1) as evidenced by Zhang (CN 120836792 A with reference made to machine translation).
Claim 1: Strickland teaches a method of manufacturing a flavored sheet ([49], Example I, film) for use in a smoking article which generates smoke and/or aerosol by combustion or heating (the film is a tobacco composition capable of being used in a smoking article), the method comprising:
preparing a sheet composition (Example I uses the film of Example B) by mixing a hydrocolloid material ([Strickland 40-41], Example B, HPMC; [applicant 47], HPMC is a hydrocolloid material), a solvent ([Strickland 40-41], water), a powdered material (microcrystalline cellulose), and a flavor (cinnamon);
and drying (the film is spread on a plate and dried) the prepared sheet composition,
wherein the powdered material (microcrystalline cellulose) remains on a surface of the flavored sheet after drying (the microcrystalline cellulose is uniformly dispersed through the sheet and would thus remain, in part, on a surface of the sheet) and increase a surface roughness of the flavored sheet (Zhang p. 5, [second to last paragraph], microcrystalline cellulose is inherently rough; one of ordinary skill would envisage that dispersing rough microcrystalline cellulose in the sheet would increase the sheet’s roughness),
and wherein the powdered material (microcrystalline cellulose) is a bulking agent (the microcrystalline cellulose has bulk).
Claim 2: Strickland teaches the method of claim 1, wherein the hydrocolloid material ([40-41], Example B, HPMC) comprises a modified cellulose material ([applicant 48], HPMC is a modified cellulose derivative).
Claim 3: Strickland teaches the method of claim 2, wherein the modified cellulose material comprises hydroxypropylmethyl cellulose ([40-41], Example B, HPMC).
Claim 4: Strickland teaches the method of claim 1, wherein the drying of the prepared sheet composition comprises:
applying the prepared sheet composition ([49], Example I, the film is spread on a plate and dried);
and adding a second powdered material ([49], flakes formed from a second film are added to the first film; [37], particles added to films can be flakes or powders) to the applied sheet composition and drying ([49], the combined film and powder are spread on a plate and dried) a mixture of the sheet composition (film) and the second powdered material (powder),
wherein the second powdered material is a bulking agent (the powder has bulk).
Claim 10: Strickland teaches the method of claim 1, wherein the emulsifier is optional.
Claim 12: Strickland teaches the method of claim 1, wherein the sheet composition further comprises a plasticizer ([40-41], Example B, glycerine; [28], glycerine is a plasticizer) that comprises glycerin.
Claim 5 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Strickland (US 20050244521 A1) as evidenced by Zhang (CN 120836792 A with reference made to machine translation) as applied to claim 1 and further evidenced by “Laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council” (hereinafter Commission Regulation).
Claim 5: Strickland teaches the method of claim 1, wherein the powdered material ([Strickland 40-41], Example B, microcrystalline cellulose) is a material that is insoluble in the solvent (Commission Regulation p. 163-164, microcrystalline cellulose is insoluble in water).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Strickland (US 20050244521 A1) as evidenced by Zhang (CN 120836792 A with reference made to machine translation) as applied to claim 1 and further evidenced by “Laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council” (hereinafter Commission Regulation) and in view of Lekwauwa (US 5327917 A).
Claim 6: Strickland teaches the method of claim 1, wherein the solvent is deionized water ([40-41], Example B, deionized water), and the powdered material (microcrystalline cellulose) has a negligible solubility in distilled water at 25 °C (Commission Regulation p. 163-164, microcrystalline cellulose is insoluble in water).
Strickland does not explicitly teach that the deionized water is distilled water.
Lekwauwa teaches a method of manufacturing a flavored sheet (col. 6, lines 17-18, sheet) comprising adding a hydrocolloid material (col. 3, lines 43-66, alginate and cellulose derivatives) and essentially pure water that can be alternatives of deionized and distilled (col. 3, lines 9-11).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute Lekwauwa’s distilled water for Strickland’s deionized water, because doing so would be a simple substitution of essentially pure waters between flavored sheets.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Strickland (US 20050244521 A1) as evidenced by Zhang (CN 120836792 A with reference made to machine translation) as applied to claim 1 in view of Cheng (US 20090022856 A1).
Claim 8: Strickland teaches the method of claim 1.
Strickland does not explicitly teach that the bulking agent comprises β-cyclodextrin.
Cheng teaches a method of manufacturing a flavored sheet ([42], Example 1, film) comprising adding a powdered bulking agent that can be equivalent alternatives of microcrystalline cellulose and β-cyclodextrin [17].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute Cheng’s β-cyclodextrin for Strickland’s microcrystalline cellulose, because doing so would be a simple substitution of bulking agents between flavored sheets.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Strickland (US 20050244521 A1) as evidenced by Zhang (CN 120836792 A with reference made to machine translation) as applied to claim 1 in view of Penhasi (“A novel nicotine pectinate salt formulated in a specific time-controlled delivery system: A new approach for colon-targeted nicotine release”).
Claim 11: Strickland teaches the method of claim 1, wherein the sheet composition comprises low methoxyl (LM) pectin ([28], lo methoxy pectin).
Penhasi teaches a method of manufacturing a flavored consumable (p. 3, Table 1, formulation) comprising adding a hydrocolloid material (HPMC) and a low methoxyl pectin (pectin; p. 2, Section 2.1 Materials, the pectin is a low methoxyl pectin), such that the low methoxyl pectin binds nicotine into nicotine pectinate which enables a controlled release of nicotine within the body (p. 6, Section 4. Conclusion).
Penhasi’s formation of nicotine pectinate by low methoxyl pectin and corresponding controlled release of nicotine are agnostic to Penhasi’s intended use to yield expectation to succeed. One of ordinary skill would be motivated to combine a hydrocolloid material and a low methoxyl pectin, as in Penhasi, for the same benefit of a controlled nicotine release.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to incorporate, from Strickland’s list of suitable species, Penhasi’s low methoxyl pectin, because doing so would enable the low methoxyl pectin to bind nicotine into nicotine pectinate which enables a controlled release of nicotine within the body.
Response to Arguments
Applicant’s arguments of 2026 September 4 have been carefully considered but are not persuasive.
Applicant argues (p. 10, [3-4]) that Strickland does not teach that a powdered material remains on a surface of a sheet after drying and increases the surface roughness of the sheet. However, Strickland does teach that a powdered material ([Strickland 40-41], microcrystalline cellulose) remains on a surface of a sheet after drying (the microcrystalline cellulose is uniformly dispersed in the sheet and would thus remain, in part, on a surface of the sheet) and increases the surface roughness of the sheet (Zhang p. 5, [second to last paragraph], microcrystalline cellulose is inherently rough; one of ordinary skill would envisage that dispersing rough microcrystalline cellulose in the sheet would increase the sheet’s roughness).
Applicant argues (p. 10, [4] – p. 11, [2]) that Lekwauwa, Cheng, Tanaka, and Penhasi have not been shown to teach that a powdered material increases surface roughness of a sheet. However, as in the above analysis, Strickland teaches that a powdered material increases surface roughness of a sheet.
Applicant argues (p. 11-12, “Feature 1”) that Strickland teaches a sheet intended for ingesting, rather than inhaling. However, amended claim 1 recites inhaling as an intended use of the sheet and does not impart positive structure to the sheet. Strickland discloses every step of the method of manufacturing a flavored sheet and thus anticipates the claim. See MPEP 2111.02(II): if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999); Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81; STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000).
Applicant reiterates (p. 12-13, “Feature 2”) that Strickland does not teach that a powdered material remains on a surface of a sheet after drying and increases the surface roughness of the sheet. However, Strickland does teach that a powdered material ([Strickland 40-41], microcrystalline cellulose) remains on a surface of a sheet after drying (the microcrystalline cellulose is uniformly dispersed in the sheet and would thus remain, in part, on a surface of the sheet) and increases the surface roughness of the sheet (Zhang p. 5, [second to last paragraph], microcrystalline cellulose is inherently rough; one of ordinary skill would envisage that dispersing rough microcrystalline cellulose in the sheet would increase the sheet’s roughness).
Applicant reiterates (p. 13-14, “Additional argument”) that Lekwauwa, Cheng, Tanaka, and Penhasi have not been shown to teach that a powdered material increases surface roughness of a sheet. However, as in the above analysis, Strickland teaches that a powdered material increases surface roughness of a sheet.
Conclusion
THIS ACTION IS MADE FINAL. 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 Tobey C. Le whose telephone number is (703)756-5516. The examiner can normally be reached Mon-Thu 8:30-18:30 ET.
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/TOBEY C LE/Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747
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