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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/18/25 has been entered.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 8-13, 16, 17, 19-27, 29-33 are rejected under 35 U.S.C. 103 as being unpatentable over Ballesteros et al. (WO 2018/100366).
Claims 1, 2, and 32. Ballesteros et al. discloses an aerosol-generating device comprising a smoking article and a heat source and a method of using the device. The smoking article (delivery system) includes a smokable material (aerosol-generating material) and a cooling agent, the smokable material including a tobacco component (Abstract). Particularly suitable cooling agents comprise WS-3 (Page 21, lines 2-11). The smokable material may comprise cooling agent and/or menthol in any suitable amount (Page 22, lines 16-24).
Ballesteros et al. does not explicitly disclose that the amount of cooling agent included provides on average at least about 1.5 µg of the cooling agent in a 35 mL puff, or no more than about 100 µg of the cooling agent in a 35 mL puff. However, differences in concentration generally do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP §2144.05(II)(A)).
Claims 3, 4, and 33. Ballesteros et al. discloses smokable material may additionally comprise a cooling agent as defined herein and/or menthol. For instance, the cooling agent may comprise a compound or compounds according to formula (I), (la), (lb), (II) or (Ila), and/or menthol (Page 29, line 28 – Page 30, line 6). Menthol is optionally applied to the tobacco component (Page 2, line 12).
Claims 8-10. Ballesteros et al. discloses that the smoking article (delivery system) is a device in which the smokable material is not burned or combusted (Page 8, lines 2-20). Ballesteros et al. does not explicitly disclose that the amount of cooling agent included provides on average at least 1.5 µg, at least about 2 µg, or no more than about 100 µg of the cooling agent in a puff under the Health Canada Intense (HCI) smoking regime. However, differences in concentration generally do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP §2144.05(II)(A)).
Claims 11-13. Ballesteros et al. discloses that the smokable material may comprise cooling agent and menthol in any suitable amount (Page 22, lines 16-24) but does not explicitly disclose that at least 0.1 mg or at least 0.3 mg, at least 1 mg, or no greater than 10 mg or no greater than 2.5 mg of the cooling agent WS-3 is included in the delivery system. However, differences in concentration generally do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP §2144.05(II)(A)).
Claims 16 and 17. Ballesteros et al. discloses that the smokable material may comprise cooling agent and menthol in any suitable amount (Page 22, lines 16-24) but does not explicitly disclose that the delivery system contains at least 0.8 mg of cooling agent WS-3 per 1 g of aerosol-generating material, or no greater than 15 mg or no greater than 11 mg of cooling agent WS-3 per 1 g of aerosol-generating material. However, differences in concentration generally do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP §2144.05(II)(A)).
Claims 19 and 20. Ballesteros et al. discloses that the cooling agent WS-3 is applied to a tobacco component to form a smokable material. The smokable material is combined with a filter to provide a smoking article (Page 2, lines 8-14).
Claim 21. Ballesteros et al. discloses that the smoking material and/or the filter and/or the paper foil lining include a cooling agent (Claim 17).
Claims 22-24. Ballesteros et al. discloses that the cooling agent may be located anywhere in the smoking article, such as in or on the smokable material or in the filter (Page 22, lines 6-9).
Claims 25-27. Ballesteros et al. discloses a method of manufacturing a smoking article for use with an aerosol-generating device, the method comprising: applying a cooling agent comprising a compound according to formula (I) or (II) to a tobacco component to form a smokable material; optionally, applying menthol to the tobacco component (thus, the tobacco component can comprise no menthol); and combining the smokable material with a filter to provide a smoking article (Page 2, lines 8-13). Particularly suitable cooling agents comprise WS-3 (Page 21, lines 2-11).
Claims 29-31. Ballesteros et al. discloses that the cooling agent may be located anywhere in the smoking article, such as in or on the smokable material or in the filter (Page 22, lines 6-9).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Ballesteros et al. (WO 2018/100366) in view of Kadiric (WO 2013/164706).
Claim 28. Ballesteros et al. discloses the method of claim 25 but does not explicitly disclose that the cooling agent is applied to at least a portion of the wrapper surrounding the aerosol generating material.
Kadiric discloses a smoking article (delivery system) comprising a tobacco substrate portion (aerosol-generating material) and a mouthpiece portion. The mouthpiece includes a cooling agent inclusion complex on an outer surface of the mouthpiece (Page 1, lines 3-4). The cooling agent is a carboxamide containing compound, such as WS-3 (Page 3, line 14 - Page 4, line 6). The smoking article preferably includes between about 0.01 mg and about 10 mg of the cooling agent, more preferably between about 0.01 mg and about 2 mg, and most preferably between about 0.05 mg and about 1 mg (Page 9, lines 23-25). Kadiric discloses that the cooling agent inclusion complex can be disposed on tipping paper. The tipping wrapper is disposed about at least a portion of a smoking article mouthpiece and joins the mouthpiece such as filter element to a tobacco substrate (thus, the tipping paper and cooling agent surround at least a portion of the aerosol generating material) (Page 2, lines 3-21).
Kadiric teaches that inclusion complex remains on the applied surface of the tipping wrapper during the manufacturing of the smoking article. In some embodiments the inclusion complex coated tipping wrapper travels through the tipping wrapper rollers, drums, breakers and wrapper operations. Surprisingly the inclusion complex remains stable, active and in place on the tipping wrapper through all these operations. Then the tipping wrapper can be applied to the mouthpiece of a smoking article, such as a filter element, for example to form the smoking article. The inclusion complex of cooling agent remained stable, active and in place on the tipping wrapper for at least six months. Thus, without the use of additional barrier layers or coatings, the cooling agent did not migrate from the applied surface of the tipping wrapper and provided physiological cooling sensation to the user's lips following six months of storage of the smoking article (Page 8, line 25 – Page 9, line 13). It would have been obvious to one of ordinary skill in the art before the effective filing date that the cooling agent may be applied to the wrapper surrounding the aerosol generating material of the smoking article of Ballesteros et al. so that it remains stable, active and in place on the tipping wrapper for at least six months as taught by Kadiric.
Allowable Subject Matter
Claims 5-7, 14, and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Ballesteros et al. discloses the delivery system of claim 1 but does not disclose or suggest that the delivery system is a combustible aerosol provision system.
Response to Arguments
Applicant's arguments filed 12/18/25 have been fully considered but are not persuasive.
Applicant argues that Ballesteros does not teach a cooling agent WS-3 present in the aerosol generating material wherein the amount of cooling agent WS-3 provides a cooling sensation upon use of the delivery system without any minty or other characteristic flavor. Examiner disagrees, as Ballesteros explicitly discloses that “the cooling agent may be located anywhere in the smoking article, such as in or on the smokable material or in the filter. In a preferred case, the cooling agent may be located in the smokable material. The cooling agent may be impregnated into the smokable material” (Page 22, lines 6-9).
Applicant alleges that the cooling agent WS-3 exhibits a desirable cooling or cleansing sensation without added flavor when it is included in the appropriate amount. Applicant also alleges that the particular amount of WS-3 incorporated into the delivery system has the unexpected benefit of not migrating within the product prior to use such that the amount delivered to the consumer is closely correlated to the amount included in the product. However, a showing of unexpected results must be based on evidence, not argument or speculation. In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. Cir. 1997). Once a prima facie case of obviousness is made by the USPTO through citation of references, the burden is on the applicant to produce contrary evidence (See MPEP §2145). Since Applicant has not provided evidence of the alleged unexpected results, Examiner finds that a prima facie case of obviousness still exists.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Katherine A Will whose telephone number is (571)270-0516. The examiner can normally be reached Monday-Friday 10:00AM-6:00PM(EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael 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.
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/KATHERINE A WILL/Primary Examiner, Art Unit 1747