DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 1-16 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of Woodcock et al (US. Pat. No. 8,893,724) (hereinafter Woodcock ‘724) in view of Waddell et al (US. Pat. No. 4,967,772).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Woodcock ‘724 generally encompass those of the afore-mentioned instant claims, but for the amended “so as to provide a gradually increasing amount of aerosol generating agent” recitation. However, the Waddell et al reference teaches deploying microcapsules (read: aerosol generating agent) with varying shell materials, shell thickness and melt temperatures such that it would have been obvious to one having ordinary skill in the art as of the effective filing date of the claimed invention to have incorporated the same into the heat-not-burn product of the Woodcock ‘724 claims which would predictably yield a gradually increasing aerosol generating release profile.
Claims 17-18, 20 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of Woodcock et al (US. Pat. No. 8,893,724) (herein after Woodcock ‘724) in view of Clearman et al (US. Pat. No. 4,756,318).
The claims of modified Woodcock et al fail to recite the further limitations in the above-listed claims; however, Clearman et al discloses unencapsulated aerosol generating agents, capsulated components, and heat source/aerosol generating components. And, given the disclosure in Clearman et al it would have been obvious to one having ordinary skill in the art as of the effective filing date of the claimed invention to have chosen to include these elements into the heat not burn product recited in modified Woodcock ‘724.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-13, 15-18, 20 and 23-24 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Clearman et al (US. Pat. No. 4,756,318) in view of Waddell et al (US. Pat. No. 4,967,772).
Regarding independent claim 1, and dependent claim 23, Clearman et al discloses a smoking article which includes a combustible carbonaceous fuel element (10) (read: “heat source”) located at a lighting/fuel end (13) of the article; a heat conductive container (12) which encloses a substrate bearing an aerosol-forming substance (read: aerosol generating agent), which may comprise a glycerin (glycerol) or propylene glycol (read: polyol); wherein a tobacco jacket (20) encircles both of said fuel element (10) and container (12). See Figure 1.
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Located in abutting/adjacent relationship to the tobacco jacket (20) is a plastic tube (18) which forms an aerosol delivery passageway (21) therethrough, wherein said plastic tube (18) is provided near a mouth end of the smoking article (see col. 6, line 53-col. 7, line 26).
During use, the smoker lights the lighting end (13) of the smoking article using a match/lighter which causes the fuel element (10) to generate heat which is provided to volatilize aerosol-forming material in the container (12) which is then inhaled by the user.
The Clearman et al smoking article yields visible mainstream aerosol that resembles the mainstream tobacco smoke of traditional cigarettes which burn tobacco (see col. 3, lines 51-68; col. 14, lines 35-49; col. 18, lines 46-61)(corresponding to the claimed “[a] heat not burn product”, and the “wherein the heat not burn product comprises a heat source and an aerosol generating portion which is made up of discrete sections comprising tobacco” recitation of claim 23).
Clearman et al further discloses that its aerosol-forming substance can be provided in the form of heat rupturable microcapsules (see col. 14, lines 1-2). This is a clear indication that Clearman et al envisions that its aerosol-forming substance can be “encapsulated” (corresponding to the claimed “encapsulated aerosol generating agent”).
Clearman et al does not disclose that its plurality of discrete microcapsules includes microcapsules wherein said microcapsules are “released from encapsulation during use of the product, and wherein the release of the encapsulated aerosol generating agent during use of the product is controlled using different encapsulation materials or different encapsulation approaches so as to provide release of a gradually increasing amount of aerosol generating agent as the product is used”; however, it does teach that during smoking of its smoking article, the burning fuel element generates heat that progressively conducts backward and builds up near and along the aerosol generating means over successive puffs (col. 8, lines 54-66). Further, the Waddell et al reference, teaches that polyhydric alcohols (i.e., aerosol-forming agents, like glycerin) can be encapsulated, via a shell wall, such that they are dissolved only via heat when the tobacco product is lighted (see col. 10, lines 6-21). Waddell et al discloses that encapsulation isolates the alcohol and provides for the controlled release thereof until such time as the heat of the smoke causes the shell to open (see col. 10, lines 22-27). The alcohols are, thereby, automatically released so as to ensure a consistent release of the alcohol (see col. 10, lines 38-41). A shell wall construction, according to the invention, will ensure melt temperatures of between 64 - 650 degrees F, col. 10, line 53 - col. 11, line 36, wherein the rate of controlled release can either be constant, or can be varied (see col. 10, lines 53-60). Capsules having shells with varied melt temperatures can be included in a single product to ensure a constant release of alcohols therein. Also, Waddell et al discloses that the rate of control can be designed to vary and, when such is the case, the shell material, and thickness can be varied (read: different encapsulation materials/different encapsulation approaches) (see col. 10, lines 60-66).
Based on this disclosure of Waddell et al, it would have been obvious to one having ordinary skill in the art to have used, in place of the microcapsules disclosed in Clearman et al, a plurality of discrete microcapsules that are differently encapsulated such that the encapsulated aerosol generating agent is released at different times during use of the Clearman et al product, thus yielding a gradually increasing release profile, in order to receive the benefits articulated in Waddell et al - namely, preventing the premature/unintentional migration and/or release of the encapsulated material, and also enabling the encapsulated material to be released automatically for the convenience of the user so that he/she does not have to further manipulate the product to ensure a more consistent release of the microcapsule content. As such, in the modified Clearman method, the release of the aerosol generating agent is controlled as the heat from Clearman’s fuel element conducts further into the aerosol-forming substrate during use, namely because capsules with progressively higher melt temperatures or thicker shell walls reach their temperature maximum threshold thus releasing increasing amount of the aerosol-generating agent puff-by-puff. Also note that to the extent that Waddell et al describes its goal as achieving a “constant release” (see col. 10, lines 53-60), it also indicates that it can be varied, and modifying Waddell et al’s shell parameters to achieve a “gradually increasing” release is a routine optimization of a result-effective variable and one having ordinary skill in the art as of the effective filing date of the claimed invention would have readily made the necessary adjustments of the parameter ratios to ensure the desire aerosol delivery (corresponding to the claimed “wherein the release of the encapsulated aerosol generating agent during use of the product is controlled using different encapsulation materials or different encapsulation approaches”; and the “wherein the timing of the release of the aerosol generating agent during use of the product is determined by at least one of: use of two or more different barrier materials to encapsulate the aerosol generating material, the barrier materials having different melting points…” recitation of claim 2; the “wherein the aerosol generating agent is at least one of a polyol…” recitation of claim 4; and the “wherein the polyol is at least one selected from the group consisting of:…glycerol...” recitation of claim 5).
Hence, the modified Clearman et al product meets the limitations of the afore-mentioned claims.
Regarding claim 3, Applicant has recited “wherein the release of the aerosol generating agent is spread over the whole period of use of the product”; but Applicant is reminded that since the instant claims are drawn to a “product” the claims are distinguished from the prior art in terms of “physical characteristics” (i.e., what it is) as opposed to function (i.e., what it does). Since the instant claim limitation does not appear to further limit the claim from which it depends (independent claim 1) physically, the claim will not be given patentable weight as it is expected that the function recited in the claim would be capable of being carried out by the modified Clearman et al product as such product meets the physical limitations of independent claim 1.
Regarding claim 6-8, since these claims reflect the “non-polyol” option from claim 4, but the “polyol” option was chosen for examination, these claims do not further limit the examined portion of claim 4.
Regarding claim 9, Waddell et al states that substances, such as gelatin, can be used as the encapsulation material (see col. 10, line 53 - col. 11, line 36) (corresponding to the claimed “wherein the barrier material is at least one selected from the group consisting of…a gelatin”).
Regarding claims 10-13, since these claims reflect the “polysaccharide”, “cellulose barrier material”, “gum” and “gel” option from claim 9, but the “gelatin” option was chosen for examination, these claims do not further limit the examined portion of claim 9.
Regarding claims 15-16, Applicant has recited “wherein the aerosol generating agent is released during use of the heat not burn product so as to provide a substantially constant/gradually increasing delivery of total particulate matter per puff”, but Applicant is reminded that since the instant claims are drawn to a “product” the claims are distinguished from the prior art in terms of “physical characteristics” (i.e., what it is) as opposed to function (i.e., what it does). Since the instant claim limitation does not appear to further limit the claim from which it depends (independent claim 1) physically, the claim will not be given patentable weight as it is expected that the function recited in the claim would be capable of being carried out by the modified Clearman et al product as such product meets the physical limitations of independent claim 1.
Regarding claims 17-18, Waddell discloses that unencapsulated alcohols (glycerol) can also be added into its product (see col. 12, lines 38-40). Hence, it would have been obvious to one having ordinary skill in the art as of the effective filing date of the claimed invention to have chosen to provide a mixture of both encapsulated and unencapsulated aerosol generating agents into the modified Clearman et al product in order to provide for both a more instantaneous as well as a controlled release of aerosol during smoking (corresponding to the “comprising one or more unencapsulated aerosol generating agents” recitation of claim 17; and the “wherein the unencapsulated aerosol generating agent is glycerol” recitation of claim 18).
Regarding claim 20, the heat conducting container (12) (see Fig. 1) of Clearman et al is considered to be a macro-capsule, which is separate from the aerosol-generating-agent-containing microcapsules (which would inherently also flavor the aerosol), but encloses the same, thus satisfying the “wherein the further encapsulated component is at least one selected from the group consisting of…flavourants”.
Regarding independent claim 24, as discussed above the modified Clearman et al invention suggests all that is recited in independent claim 1 and, hence, would inherently suggest the claimed function of that which is claimed, which includes “release of a gradually increasing amount of the aerosol generating agent as the product is used is achieved by at least one of…encapsulating the aerosol generating agent with two or more different barrier materials, the barrier materials having different melting points”).
Response to Arguments
Applicant's arguments filed in its “Remarks” on July 9, 2026 have been fully considered but they are not persuasive.
-Applicant primarily argues that:
1) Waddell et al is directed to a different purpose (reducing nitrosamine harm in conventional combustible cigarettes using nitrosamine blocking agents) and, hence, does not teach or suggest controlling release to provide a “gradually increasing amount” of aerosol-generating agent or improving sensory experience. The Examiner disagrees. Both the instant application and Waddell et al belong to the field of smoking articles and, specifically, the microencapsulation of volatile agents for heat-triggered release into a mainstream smoke/aerosol stream. Waddell et al explicitly lists polyhydric alcohols - including glycerol and 1,2-propanediol - as active agents encapsulated within heat-triggerable microcapsule placed in a smoking article. Glycerol and propylene glycol are the exact aerosol-generating agents recited in Applicant’s specification. Releasing microencapsulated glycerol or propanediol into a heated airflow inherently generates an aerosol, regardless of the underlying motivation (nitrosamine blocking vs. sensory enhancement) envisioned by the invention. Note that a reference is available for all that is teaches, including its structure and chemical compositions, and is not limited to its stated primary purpose (see MPEP 2141.02 - In re Wiseman, 596 F.2d 1019, 1022 (CCPA 1979).
2) Waddell et al seeks uniform delivery across every puff, which teaches away from or fails to suggest a gradually increasing release profile. The Examiner disagrees. When a person having ordinary skill in the art incorporates Waddell et al’s microcapsules - having varied shell thicknesses and melt temperatures - into Clearman’s thermal system, the result in a predictably gradually increasing release profile. As smoking progresses and heat from Clearman’s fuel element conducts further along the substrate, capsules with progressively higher melting points or thicker walls sequentially reach their thermal melt thresholds thereby releasing increasing quantities of polyhydric agent puff-by-puff. Waddell et al expressly establishes shell wall thickness, capsule size, and melting point as result-effective variables used to adjust aerosol-generating agent release in response to heat. It has been established by the Courts that where the prior art recognizes a parameter (e.g., capsule wall thickness) controls a particular characteristic (rate or timing release), optimizing that parameter to achieve a desired profile constitutes routine optimization (see MPEP 2144.05 - In re Aller, 220 F.2d 454,456). In this instance, adjusting the relative ratio of capsules with different melting temperatures to alter the aerosol delivery curve is an application of routine experimentation.
3) The Examiner’s rejection relies on impermissible hindsight. The Examiner disagrees, and submits that she has not relied on hindsight, but on the explicit structural capabilities of the prior art references under the legal framework of KSR Intl Co. v. Teleflex Inc., 550 U.S. 398 (2007). The test for obviousness under 35 USC 103 is not whether the prior art references express the exact same subjective motivation or rationale as Applicant, but whether one having ordinary skill in the art would have had a reasonably expectation of success in combining the structural teachings to achieve controlled release (See MPEP 2143).
In sum, because Clearman in view of Waddell et al teaches every structural limitation of claim 1, and because adjusting the encapsulation barrier parameters to control release rate is a routine optimization of result-effective variables disclosed in Waddell et al, the claims are still obvious over the combined references, and the withdrawal of the rejection is denied.
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 DIONNE WALLS MAYES whose telephone number is (571)272-5836. The examiner can normally be reached Mondays and Thursdays, 8:00AM - 4:00PM (EST).
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/DIONNE W. MAYES/Primary Examiner, Art Unit 1747
