CTNF 18/567,894 CTNF 99593 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 08-25-01 AIA Applicant’s election without traverse of Group I (claims 1-12) in the reply filed on 2026 May 4 is acknowledged. Claims 13-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Specification 07-29 AIA The disclosure is objected to because of the following informalities: [56]: “a material that contains less than 50% of carboxyl groups in its molecular structure” should be “a material that contains less than 50% carboxyl groups in its molecular structure” . Appropriate correction is required. Claim Objections 07-29-01 AIA Claim s 4 and 11 are objected to because of the following informalities: Claim 4: “adding a powdered material” should be “adding a second powdered material” to differentiate from the powdered material of claim 1. Claim 11: “a material that contains less than 50% of carboxyl groups” should be “a material that contains less than 50% carboxyl groups by molecular weight” or equivalent . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claim 11 is 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 11: the claim defines that low methoxyl pectin “has a property of not being gelated when cooled”, but low methoxyl pectin can be gelated when cooled. Notwithstanding the fact that “cooled” is relative and renders the claim indefinite, because neither the claim nor the specification sets a standard for cool versus warm, Zepp (“Ask Martha: Low Methoxyl Pectin”) teaches that low methoxyl pectin can be gelated (description) for the purpose of creating jam in a freezer (2:07 and 2:12 timestamps). The limitation “and has a property of not being gelated when cooled” is interpreted as omitted to make the claim examinable. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (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. 07-15 AIA Claim s 1-4, 7, 9, and 12 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Strickland (US 20050244521 A1) . Claim 1: Strickland teaches a method of manufacturing a flavored sheet ([49], Example I, film), 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 PGMS), and a flavor (cinnamon); and drying (the film is spread on a plate and dried) the prepared sheet composition. 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). Claim 7: Strickland teaches the method of claim 1, wherein the powdered material ([40-41], Example B, microcrystalline cellulose) is a bulking agent (microcrystalline cellulose has bulk). Claim 9: Strickland teaches the method of claim 1, wherein the powdered material ([40-41], Example B, PGMS) is an emulsifier. Claim 12: 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 . 07-15 AIA Claim s 5 is rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Strickland (US 20050244521 A1) as applied to claim 1 and 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 07-20-aia AIA 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. 07-21-aia AIA Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Strickland (US 20050244521 A1) as applied to claim 1 and 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 . 07-21-aia AIA Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Strickland (US 20050244521 A1) as applied to claim 7 in view of Cheng (US 20090022856 A1) . Claim 8: Strickland teaches the method of claim 7. Strickland does not explicitly teach that the powdered material 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 . 07-21-aia AIA Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Strickland (US 20050244521 A1) as applied to claim 9 in view of Tanaka (US 20130327346 A1) . Claim 10: Strickland teaches the method of claim 9. Strickland does not explicitly teach that the emulsifier comprises sucrose ester. Tanaka teaches a method of manufacturing a flavored sheet (title) comprising adding an emulsifier that can be equivalent alternatives of propylene glycol monostearate and a sucrose ester [99-100]. 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 Tanaka’s sucrose ester for Strickland’s propylene glycol monostearate, because doing so would be a simple substitution of emulsifiers between flavored sheets . 07-21-aia AIA Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Strickland (US 20050244521 A1) 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), which is a material that contains less than 50% carboxyl groups by molecular weight. 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. Conclusion 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. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael H. Wilson can be reached at 571-270-3882. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /TOBEY C LE/Examiner, Art Unit 1747 /Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747 Application/Control Number: 18/567,894 Page 2 Art Unit: 1747 Application/Control Number: 18/567,894 Page 3 Art Unit: 1747 Application/Control Number: 18/567,894 Page 4 Art Unit: 1747 Application/Control Number: 18/567,894 Page 5 Art Unit: 1747 Application/Control Number: 18/567,894 Page 6 Art Unit: 1747 Application/Control Number: 18/567,894 Page 7 Art Unit: 1747 Application/Control Number: 18/567,894 Page 8 Art Unit: 1747 Application/Control Number: 18/567,894 Page 9 Art Unit: 1747 Application/Control Number: 18/567,894 Page 10 Art Unit: 1747
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