DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/6/2026 has been entered.
Status of the Claims
Claims 1-35 are pending. Claims 22-35 are withdrawn. Claims 1, 8, and 18 have been amended.
Response to Arguments
Applicant's arguments filed 1/6/2026 have been fully considered but they are not persuasive.
Applicant argues that “Stenzler describes that menthol in the form of crystals, can be processed into particles of a size ranging from about 5µm to about 10µm (see paragraph 63)”, so “Stenzler provides no disclosure or suggestion of particles incorporating a volatile component having an average particle size of 0.1 to 3 mm as presently claimed”. This argument is not persuasive as Stenzler also teaches in ¶ 0066 that “menthol . . . produced as previously described herein” (e.g., menthol crystals as previously described in ¶ 0063) include “particles . . . sized between about 10 and 1000 micron” (¶ 0066). Since the range 0.01 to 1 mm overlaps the claimed range of 0.1 to 3 mm, a prima facie case of obviousness exists (MPEP § 2144.05(I)). It has been held that a “reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments” (Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989), MPEP § 2123(I)).
Applicant further argues that “since the formulations of Stenzler are not heated in use, in contrast to the aerosol generating material of the present invention, the particles of menthol in the formulations of Stenzler need to be in the micrometer range to allow the user to aerosolize the particles by inhalation only”. However, this is a conclusory statement not found in any evidence of record and is, therefore, not persuasive as “[t]he arguments of counsel cannot take the place of evidence in the record.” (MPEP § 716.01(c), citing In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Applicant then argues that Stenzler provides no teaching, suggestion, or motivation for modifying White. This argument is not persuasive as Stenzler provides a motivation for making the menthol crystals taught by White have the particle size disclosed by Stenzler (see ¶ 0041 of Stenzler and the rejection of claim 1 below).
Claim Rejections - 35 USC § 112
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.
Claims 1-21 are 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.
Regarding claim 1, claim 1 recites both “at least one particle” and “an average particle size”, making it unclear to one of ordinary skill in the art if claim 1 requires more than one particle. For the purpose of this Office action, claim 1 is interpreted as allowing for either possibility.
Claims 2-21 are indefinite due to their dependence from claim 1.
Further regarding claims 4, 12-14, 19, and 20, each claim recites the limitation "the particles”. There is insufficient antecedent basis for this limitation in the claim. For the purpose of this Office action, “the particles” in claims 4, 12-14, 19, and 20 is interpreted as “the at least one particle”.
Further regarding claims 12 and 14, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 12 recites the broad recitation "no greater than 3 mm", and the claim also recites "no greater than 1 mm, no greater than 0.5 mm, or no greater than 0.3 mm" which is the narrower statement of the range/limitation. Further, claim 14 recites the broad recitation "no greater than 1 mm", and the claim also recites "no greater than 0.5 mm, or no greater than 0.3 mm" which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For the purpose of this Office action, the narrower ranges are interpreted as not required.
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 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 1-8 and 12-21 are rejected under 35 U.S.C. 103 as being unpatentable over White (US 2019/0269170 A1) in view of Stenzler et al. (US 2016/0198758 A1).
Regarding claim 1, White discloses an aerosol generating material (“pellet substrates 31”, Fig. 2, ¶ 0081, which “produce an aerosol”, ¶ 0081) comprising at least one particle incorporating a volatile component in solid form within a composition (the pellet comprises a “flavoring”, ¶ 0002, which may be “menthol crystals”, ¶ 0054), and at least one particle (“tobacco powder blend comprising . . . tobacco milled to a very fine particle”, ¶ 0081(§F)) comprising an active ingredient (White discloses that tobacco material comprises the active ingredient nicotine, “dry tobacco material as the substrate to be heated to release the aerosol containing nicotine”, ¶ 0007).
White does not explicitly disclose wherein the volatile component has a vapor pressure at 20°C which is greater than or equal to the vapor pressure of the active substance at 20°C, and wherein the release of the active substance from the aerosol generating material is controlled by competition with the release of the volatile component.
However, when a composition is claimed in terms of its properties, the prior art is not required to explicitly state that property (MPEP § 2112(III)). In the instant case, as the volatile component and active substance of White are menthol and nicotine, respectively, which are the same compounds taught by Applicant (see, e.g., claims 7 and 3 of the Application), the compounds of White will inherently have the same properties. (See MPEP § 2112.01(I): “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977); “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)).
White does not explicitly disclose the particle size of the particles incorporating the volatile component to determine if they have an average particle size of 0.1 to 3 mm.
Stenzler, in the same field of endeavor, discloses that particles incorporating a volatile component can have a particle size of 0.01 to 1 mm (“In one embodiment, menthol is in the form of crystals.”, ¶ 0063; “the formulation may optionally include a flavor component, wherein the particles of the flavor component are sized between about 10 and 1000 micron. In one embodiment, the flavor component comprises menthol and may be produced as previously described herein.”, ¶ 0066). One of ordinary skill in the art would have understood that there was a benefit to forming the particles incorporating the volatile component to have this particle size as it facilitates desired flavor and delivery (¶ 0041). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to form the particles incorporating the volatile component taught by White to have the particle size taught by Stenzler in order to obtain this benefit. The range of 0.01 to 1 mm overlaps the claimed range of average particle size of 0.1 to 3 mm (MPEP § 2144.05(I)).
Regarding claim 2, White in view of Stenzler teaches an aerosol generating material as claimed in claim 1, as stated above. White further discloses that the aerosol generating material is for inclusion in an aerosol provision system (“vapor delivery devices 10”, Fig. 1, ¶ 0081).
Regarding claim 3, White in view of Stenzler teaches an aerosol generating material as claimed in claim 1, as stated above. White further discloses wherein the active substance is nicotine (“nicotine”, ¶ 0007).
Regarding claim 4, White in view of Stenzler teaches an aerosol generating material as claimed in claim 1, as stated above. White further discloses wherein the at least one particle comprising the active substance is a tobacco particle (“tobacco milled to a very fine particle”, ¶ 0081(§F)).
Regarding claim 5, White in view of Stenzler teaches an aerosol generating material as claimed in claim 1, as stated above. White does not explicitly disclose that the vapor pressure of the volatile component is at least 6 Pa at 20°C. However, when a composition is claimed in terms of its properties, the prior art is not required to explicitly state that property (MPEP § 2112(III)). In the instant case, as the volatile component of White is menthol, which is the same compound taught by Applicant (see, e.g, claim 7 of the Application), the volatile compound of White will inherently have the same properties. (See MPEP § 2112.01(I): “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977); “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)”).
Regarding claim 6, White in view of Stenzler teaches an aerosol generating material as claimed in claim 1, as stated above. White further discloses wherein the volatile component is a volatile flavor (“Menthol flavoring”, ¶ 0054).
Regarding claim 7, White in view of Stenzler teaches an aerosol generating material as claimed in claim 6, as stated above. White further discloses wherein the volatile component is menthol (“menthol”, ¶ 0054).
Regarding claim 8, White in view of Stenzler teaches an aerosol generating material as claimed in claim 1, as stated above. White further discloses that multiple flavors may be incorporated into the aerosol generating material (“other volatile aromas and/or flavoring, such as coffee, tea, cocoa, oak, hickory and the like”, ¶ 0054). As such, the volatile component of menthol would not itself impart a characterizing flavor to the aerosol generating material.
Regarding claim 12, White in view of Stenzler teaches an aerosol generating material as claimed in claim 1, as stated above. White further discloses wherein the at least one particle comprising an active substance have an average diameter no greater than 3 mm (“less than about 20 microns”, ¶ 0081(§F)). Since the range less than about 20 microns falls within the claimed range of no greater than 3 mm, the range is anticipated (MPEP § 2131.03).
Regarding claim 13, White in view of Stenzler teaches an aerosol generating material as claimed in claim 1, as stated above. White further discloses wherein the at least one particle incorporating a volatile component is at least one particle that consists of the volatile component (“menthol crystals”, ¶ 0054).
Regarding claim 14, White in view of Stenzler teaches an aerosol generating material as claimed in claim 1, as stated above. Stenzler further discloses that the at least one particle incorporating the volatile component has a diameter no greater than 1 mm (“In one embodiment, menthol is in the form of crystals.”, ¶ 0063; “the formulation may optionally include a flavor component, wherein the particles of the flavor component are sized between about 10 and 1000 micron. In one embodiment, the flavor component comprises menthol and may be produced as previously described herein.”, ¶ 0066; particle size is indicative of the diameter of a particle, e.g., for a sphere-shaped particle, the particle size is the diameter). The range 0.01 to 1 mm falls within the claimed range of average diameter of no greater than 1 mm (MPEP § 2131.03).
Regarding claim 15, White in view of Stenzler teaches an aerosol generating material as claimed in claim 1, as stated above. White also discloses the aerosol generating material further comprising one or more aerosol forming agent (“a pellet that is adsorbed with an aerosol former”, ¶ 0002).
Regarding claim 16, White in view of Stenzler teaches an aerosol generating material as claimed in claim 15, as stated above. White further discloses wherein the aerosol forming agent is glycerol (“aerosol formers . . . such as . . . glycerol”, ¶ 0079(§b)).
Regarding claim 17, White in view of Stenzler teaches an aerosol generating material as claimed in claim 1, as stated above. White also discloses wherein the aerosol generating material further comprising one or more binder (“the pellet substrates 31 may further comprise a water soluble gum to provide increased adhesion of additives”, ¶ 0025).
Regarding claim 18, White in view of Stenzler teaches an aerosol generating material as claimed in claim 17, as stated above. White further discloses wherein the one or more binder is a cellulose derivative (“a water soluble gum, for example a relatively low viscosity cellulose gum”, ¶ 0027).
Regarding claim 19, White in view of Stenzler teaches an aerosol generating material as claimed in claim 1, as stated above. With regards to a precursor composition comprising the at least one particle incorporating a volatile component and the at least one particle comprising an active substance being granulated or spheronized to form an agglomerated structure, this relates to the process by which the product is formed. As noted in MPEP § 2113(I), “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.). As the structure of the aerosol generating material of White appears to be the same as if the at least one particle incorporating a volatile component and the at least one particle comprising an active substance were granulated at some point in the process of making the aerosol generating material (such as prior to steps described in ¶ 0054), the claim is anticipated. (See MPEP § 2113(II)).
Regarding claim 20, White in view of Stenzler teaches an aerosol generating material as claimed in claim 1, as stated above. With regards to a precursor composition comprising the at least one particle incorporating a volatile component and the at least one particle comprising an active substance being extruded to form an agglomerated structure, this relates to the process by which the product is formed. As noted in MPEP § 2113(I), “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.). As the structure of the aerosol generating material of White appears to be the same as if the at least one particle incorporating a volatile component and the at least one particle comprising an active substance were extruded at some point in the process of making the aerosol generating material (such as prior to steps described in ¶ 0054), the claim is anticipated. (See MPEP § 2113(II)).
Regarding claim 21, White in view of Stenzler teaches an aerosol generating material as claimed in claim 1, as stated above. White further discloses wherein the aerosol generating material is in the form of granules (Fig. 2).
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over White (US 2019/0269170 A1) in view of Stenzler et al. (US 2016/0198758 A1) as applied to claim 1 above, and further in view of Plattner et al. (US 2021/0401029 A1).
Regarding claim 9, White in view of Stenzler teaches an aerosol generating material as claimed in claim 1, as stated above. White does not explicitly disclose wherein the pH of the aerosol generating material is from about 4 to about 9.5.
Plattner, in the same field of endeavor, discloses forming aerosol generating materials (mixtures including “aerosol forming agent”, Abstract) wherein the pH of the aerosol generating material is within the range of from about 4 to about 9.5 (“between 5 and 9”, ¶ 0052). One of ordinary skill in the art would have understood that there was a benefit to adjusting the pH of the aerosol forming material to be within this range as it increases the amount of “nicotine, released, or perceived as having been released by a user, which can improve sensory satisfaction” (¶ 0052). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to adjust the pH of the aerosol generating material taught by White to be within the range taught by Plattner in order to achieve this benefit. The range between 5 and 9 falls within the claimed range of from about 4 to about 9.5 (MPEP § 2131.03).
Regarding claim 10, White in view of Stenzler and Plattner teaches an aerosol generating material as claimed in claim 9, as stated above. Plattner further discloses wherein the pH is increased by the addition of one or more bases (“pH adjusting agent . . . sodium carbonate”, ¶ 0052).
Regarding claim 11, White in view of Stenzler and Plattner teaches an aerosol generating material as claimed in claim 10, as stated above. Plattner further discloses wherein the base is sodium carbonate (“sodium carbonate”, ¶ 0052).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY G CULBERT whose telephone number is (571)270-0874. The examiner can normally be reached Monday-Friday 9am-4pm.
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.
/C.G.C./Examiner, Art Unit 1747
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759