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 .
Response to Arguments
Applicant’s response from 8/21/2026 is acknowledged.
Election/Restrictions
Applicant has disagreed that claim 12 was withdrawn from consideration as directed to a non-elected species.
In response, it is noted that this argument if first made moot, because Applicant has cancelled claim 12. Second, Applicant’s response to the restriction/ election requirement from 5/4/2026 elected “a tobacco filter,” not “a capsule”, and certainly not a tobacco filter comprising a dosage form with a capsule. Applicant’s claim set from 10/11/2023, based on which the rejection was made, had no claims whatsoever directed to any such tobacco filter comprising a dosage form with a capsule. See cf. claims 1, 12, 13 and 15-17.
Notwithstanding the above, and in view of Applicant’s claim amendments, the election of species requirement is hereby withdrawn. New claim 37 is withdrawn from consideration as directed to a new and non-elected group. There is no unity of invention for Applicant’s special technical feature, as it is known in the art- see US 20230200435 A1 to Zaima et al. (“Zaima”) over which a rejeciton was made below.
Claims 1, 11, 13, 15-17 and 33-36 are pending, and have been examined herewith.
Claim Rejections - 35 USC § 102
Claim Rejections - 35 USC § 103
In view of Applicant’s claim amendments, the rejections of record are withdrawn.
A new search was performed. The closest remaining effectively filed before the effective filing date of the claimed invention art is US 20230200435 A1 to Zaima et al. (“Zaima”). Zaima does not qualify as prior art under 35 USC 102(a)(2) because it does not name another inventor.
Zaima relates to a composition comprising caryophyllene and is used for at least one selected from the following (purposes) (1) to (3) : (1) promoting relaxation, prolonging a resting-state time, and/or prolonging a motionless time, (2) promoting sleep, and (3) preventing blood pressure elevation. It also relates to a method for inhaling β-caryophyllene simultaneously with smoking a tobacco product, filter, characterized in that the tobacco product contains a β-caryophyllene-containing seamless capsule in a tobacco filter, wherein the seamless capsule contains an essential oil containing β-caryophyllene as an active ingredient. Per Zaima, pulmonary inhalation of β-caryophyllene by the above method allows β-caryophyllene to be efficiently distributed throughout the body, leading to achievements of relaxing and sleep-inducing effects, etc. (Abstract, [0022]).
Zaima further discloses: “[0025] A capsule having a core (content, liquid content) and a shell, wherein the core (content) contains caryophyllene. [0026] A filter containing caryophyllene. [0027] A filter containing a capsule (a capsule-embedded filter, a filter composed of a capsule-embedded filtration member), wherein the capsule at least comprises a first capsule, wherein the first capsule has a core (content, liquid content) and a shell, and wherein the core (content) contains caryophyllene. [0028] The filter according to the above [11], wherein the capsule further comprises a second capsule, and wherein the second capsule has a content different from that of the first capsule. [0029] The capsule or filter according to any one of the above [9], [11], and [12], wherein the core contains 1 mass% or more caryophyllene relative to the total mass of the core which is assumed as 100 mass%. [0030] The capsule or filter according to any one of the above [9], and [11] to [13], wherein the core further contains a carrier and/or a flavoring agent. [0031] The filter according to any one of the above [11] to [14], wherein the second capsule has a core (content, liquid content) and a shell, wherein the core (content) of the second capsule at least contains a flavoring agent.”
Zaima discloses “wherein the amount of the β-caryophyllene is 20 to 100% of the amount of the composition which is assumed as 100 mass%” and a capsule having a shell and a liquid content entrapped in the shell, wherein the amount of the composition in the liquid content is 20 to 100% of the amount of the liquid content which is assumed as 100%. ([0066], [0069]). Per Zaima, caryophyllene can be used in the content (core) of capsules, which are to be broken in use, or caryophyllene can be used in inhalation devices (such as e-cigarettes and heated tobacco products). ([0080]).
“[0154] The capsule may have a shell only or have a shell and a content (core). In particular, the capsule for tobacco products, etc., may have a core (content, inner liquid, inner substance) and a shell (outer layer, coat, capsule coat). [0155] The capsule may be . . . a seamless capsule. [0156] . . .when the capsule is a capsule having a core (seamless capsule), the caryophyllene may be contained in the core (or at least in the core).” “[0165] The additional ingredient is, for example, a carrier [e.g., an acid or an ester, particularly a liquid carrier (e.g., a liquid fat or oil such as an MCT, or a liquid fatty acid)], a flavoring agent (e.g., menthol).” “[0176] The capsule (e.g., the capsule having a core) may be breakable (disintegrable) (e.g., easily disintegrable or easily breakable). The crush strength of the capsule is determined according to the diameter and other factors, and may be, for example, 100 g or more, 200 g or more, 300 g or more, 400 g or more, 500 g or more, 600 g or more, 700 g or more, 800 g or more, 900 g or more, 1,000 g or more, etc.” “[0187] The capsule may be used as it is or in combination with another capsule, depending on the application and other factors. The capsule may be, for example, embedded in a filter, as described later. [0188] Said another capsule may be a capsule that does not contain caryophyllene. Said another capsule is, for example, a capsule having a core and a shell in which neither the core nor the shell contains caryophyllene.”
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 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8 and 13 of copending Application No. 17,910,672 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they disclose overlapping subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The claims of the instant application are directed to:
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The claims of the co-pending application are directed to:
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The specification of the two applications gives some examples of the capsules. Since they overlap, the capsules of the co-pending application fit Applicant’s own description of an easy-to-disintegrate capsule.
Claim Objections
Claim 37 is objected to under 37 CFR 1.75(c) as being in improper form because of a multiple dependent claim format being dependent on claim 13, which depends from claim 1. See MPEP § 608.01(n). Accordingly, the claim has not been further treated on the merits.
Claims 15-17 and 33-36 are objected to as dependent on a rejected base claim, but would be allowable if written in independent claim format.
Allowable subject matter
The application would be in condition of allowance, if Applicant proceeds to:
-Amend claim 37 to recite:
A method for suppressing an increase in arterial stiffness in a smoker, the
method comprising:
disintegrating in a tobacco filter an easy-to-disintegrate capsule comprising a composition comprising caryophyllene and a carrier, and
the smoker inhaling mainstream smoke drawn through the tobacco filter.
-Cancel claims 18-29 and 32.
-File a terminal disclaimer over co-pending patent application No. 17,910,672.
-Address the objection of claims 15-17 and 33-36.
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 SVETLANA M IVANOVA whose telephone number is (571)270-3277. The examiner can normally be reached 8:30-5:00.
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, Kortney L. Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SVETLANA M IVANOVA/ Primary Examiner, Art Unit 1627
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