DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 1-18, 20 and 23-24 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.
These claims (specifically, independent claim 2, claim 3 and independent claim 24, at least) recite either the phrase “the release” or the phrase “the timing”; however, there is insufficient antecedent basis for these limitations when they are first recited in the respective claim(s).
Response to Arguments
Applicant’s arguments in the “Remarks” filed on December 26, 2025, with respect to the rejection(s) of instant claims over the prior art of record have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made as follows:
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 Sebastian et al (US. Pat. App. Pub. 2011/0041861).
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 “a further encapsulated component encapsulated separately from the encapsulated aerosol generating agent” recitation. However, the Woodson et al reference shows that incorporating encapsulated flavor, separate from the aerosol generating means, is known in products that can be called “heat-not-burn”. 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 incorporated a further encapsulated component into the heat not burn product recited in the Woodcock ‘724 claimed invention.
Claims 17-20 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 Sebastian et al (US. Pat. App. Pub. 2011/0041861), further in view of Clearman et al (US. Pat. No. 4,756,318).
The claims of Woodcock et al modified by Sebastian 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 Woodcock ‘724/Sebastian et al.
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, 15-20 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) and Sebastian et al (US. Pat. App. Pub. 2011/0041861).
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”).
But, Clearman et al does not disclose that its plurality of discrete microcapsules includes microcapsules “wherein the release of the encapsulated aerosol generating agent during use of the product is controlled using different encapsulation materials or different encapsulation approaches”.
The Waddell et al reference, however, 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 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 thereby controlled (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: the 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).
Lastly, while the modified Clearman et al product may not disclose “a further encapsulated component encapsulated separately from the encapsulated aerosol generating agent”; Clearman et al does teach that its tobacco jacket (20) (read: separately from the encapsulated aerosol generating agent) can include flavor agents (read: component) (see col. 15, lines 57-59) Further, the Sebastian et al reference shows that alternative smoking devices (read: heat not burn products) are known to include flavorants (read: flavor agents), in any of its components, which may take the form of capsules (read: a further encapsulated component) (see para. [0044]). 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 incorporated a flavor capsule (read: encapsulated component) into the tobacco jacket (20) of the modified Clearman et al product in order to preserve and ensure the integrity of the flavor as taught in Sebastian et al (corresponding to the claimed “a further encapsulated component encapsulated separately form the encapsulated aerosol generating agent”).
Hence, the modified Clearman et al product meets the limitations of the aforementioned 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 claims 19-21, 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 “a further encapsulated component” of claim 19, the “wherein the further encapsulated component is at least one selected from the group consisting of…flavourants”; and the “wherein the further encapsulated component is encapsulated with the aerosol generating agent’ recitation of claim 21.
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 “the timing of the release of the aerosol generating agent during use of the product is determined by at least one of…encapsulating the aerosol generating agent with two or more different barrier materials, the barrier materials having different melting points”).
Conclusion
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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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.
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/DIONNE W. MAYES/Primary Examiner, Art Unit 1747