DETAILED ACTION
Previous Rejections
Applicants' arguments, filed 18 March 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The anticipation rejection and statutory double patenting rejections are withdrawn in view of the amendment to the claims. And obviousness rejections and nonstatutory double patenting rejections are withdrawn in view of the amendment to the claims, though rejections similar to them with additional art cited is applied below. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 5, 7, 16-17, and 41 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The analysis set forth for evaluating subject matter eligibility under section 101 is discussed in MPEP 2106. Step 1 is to determine if the claim is to a process, machine, manufacture, or a composition of matter. For the instantly recited invention, this is true. The claims are directed to a composition of matter. Thus, the analysis continues to step 2A.
Step 2A consists of two prongs. The first prong of step 2A is if the claim recites an abstract idea, a law of nature, or a natural phenomenon. The claims are directed to a composition of matter comprising natural phenomenon (naturally occurring materials). Thus, the claims are drawn to products of nature, and the analysis continues to the second prong of step 2A.
The second prong of step 2A is does the claim recite additional elements that integrate the judicial exception into a practical application. The claims recites a composition comprising caryophyllene and a flavoring agent. Both elements encompass naturally occurring materials (see claim 16 which states the caryophyllene can be from natural sources and paragraph [35] of the specification, which states the flavoring agents may be naturally occurring). There are no elements recited as limitations which integrate the mixture into a practical application. Thus, as there is nothing else in the claim other than the judicial exception, the analysis continues to step 2B.
Step 2B is does the claim recite additional elements that amount to significantly more than the judicial exception. The instant claims recite additional limitations to the amount of the caryophyllene and flavoring agent (claim 41). These additional limitations are not sufficient to amount to significantly more than the judicial exception. There is no limitation to the claimed invention requiring anything which is not drawn to a judicial exception. And there is nothing in the specification to indicate that the combination of these two ingredients, or their amounts, provides for any additional functionality beyond that which each substance has individually. Thus, the claims are considered to not be drawn to eligible subject matter under 35 USC 101.
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.
Claims 5, 7-8, 13, 16-17, and 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US Patent Application Publication 2020/0069683) in view of Anavi-Goffer et al. (US Patent Application Publication 2015/0051299) and Hall et al. (US Patent Application Publication 2005/0037070).
Li et al. discloses pharmaceutical capsules comprising lumateperone and optionally additional therapeutic agents (abstract). The capsule composition can be used to treat schizophrenia (paragraph [4] & claim 20). The capsule can also have a flavoring agent (paragraph [85]), such as fruit flavors (paragraph [92]).
Li et al. does not disclose that the capsule has caryophyllene, which is recited by the instant claims. Li et al. also does not specific the specific fruit flavors recited by instant claim 5.
Anavi-Goffer et al. discloses compositions comprising beta-caryophyllene for use in the treatment of schizophrenia (abstract). The composition can be a single discrete unit, such as a capsule, and have 25 to 100 mg of the caryophyllene present in the capsule (paragraph [10]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have included beta-caryophyllene into the capsule composition disclosed by Li et al. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
Hall discloses pharmaceutical formulations comprising a taste-masking material (abstract). These include capsule formulations (paragraph [161]). The flavoring agent can be apple or grape (paragraph [47]), which are flavors instantly recited.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have used apple or grape flavor for the flavoring agent in the capsule taught by Li et al. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
Instant claims 5, 7 and 13 recite limitations to the amount of caryophyllene present in the composition or capsule. The capsules exemplified by Li et al. have a weight of 300 mg (examples 2 and 3), and Anavi-Goffer et al. suggests the amount of the caryophyllene present in the capsule is 25 to 100 mg (paragraph [10]). Thus, the amount present would read upon the range instantly recited.
Instant claims 8 and 13 further limit the structure of the capsule, and the capsule disclosed by Li et al. has such a structural arrangement (examples 2 and 3).
Instant claims 16 and 17 further limit the source of the caryophyllene. Anavi-Goffer et al. does not expressly state where the caryophyllene is sourced, and thus discloses all of the limitations of the instantly recited composition except for the method by which the caryophyllene is prepared. The patent-ability of a product does not depend on its method of production, and 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. See MPEP 2113. Thus, while Anavi-Goffer et al. does not disclose the instantly recited method steps for obtaining the caryophyllene, the composition disclosed by Anavi-Goffer et al. reads on the limitations instantly recited with regards to the composition.
Instant claims 41 and 42 further limit the amount of flavoring agent present. Hall et al. suggests amounts of the flavoring agent (paragraph [136]) and these amounts provide for a range of relative ranges (with respect to the caryophyllene) which overlap the instantly recited ranges. And in cases involving overlapping ranges, where the instantly claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. See MPEP 2144.05.
Nonstatutory 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 5, 7-8, 13, 16-17, and 41-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 and 19-20 of copending Application No. 18/691,716 (reference application) in view of Hall et al. (US Patent Application Publication 2005/0037070). Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations recited by the instant claims are almost all recited by the copending claims. However, they differ in that the instant claims limit the flavoring agent, whereas the copending claims do not recite these flavoring agents (though flavoring agents in the capsule are recited therein, just not the specific ones).
This deficiency is remedied by Hall et al, which discloses pharmaceutical formulations including capsule formulations (abstract & paragraph [161]). The flavoring agent can be apple or grape (paragraph [47]), which are flavors instantly recited.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have used apple or grape flavor for the flavoring agent in the capsule recited by the copending claims. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
The Applicant argues that the rejections are all not proper. With respect to the rejection under 35 USC 101, the Applicant states that the combination of caryophyllene and the specific flavoring agents recited is not a naturally occurring combination. Thus the conclusion is the rejection is not proper. The Examiner acknowledges this argument, but does not consider it persuasive. The existence of the entire claimed combination in nature is not the standard for determining whether a rejection is proper. The reasoning was provided, and no rebuttal of the reasoning and analysis put forth was provided.
The obviousness rejection is also traversed by the Applicant. The Applicant argues that Li et al. and Anavi-Goffer et al. do not teach the specific flavoring agents instantly recited. The Applicant also argues the rejection is overcome in view of the unexpected results. In particular, the Applicant states that the specific flavoring agents instantly recited provide for increased volatilization of the caryophyllene in e-cigarettes as compared to other flavored liquid solutions.
The Examiner acknowledges these arguments, but does not consider them persuasive. With respect to the flavoring agents, newly cited Hall et al. address these limitations. As for the unexpected results, while the evidence in the instant specification is acknowledged, it is not found persuasive. There is no nexus between the claimed invention and the results demonstrated, which relate to e-cigarette use. The claims are not directed to such a product . See MPEP 716.01(b).
Further it, is unclear what differences there are between the comparative and the inventive examples. The specification states different flavoring liquid solutions are used (1-9), but does not state what specifically are the flavoring agents of each solution. In other words, for example, the 5% lemon flavoring agent of solution 2 is not specified if it is oils from lemons, lemon juice, etc. And as it is unclear thus what is the difference between the solutions, it cannot be determined how the claims relate to these differences.
The Applicant argues that the nonstatutory double patenting rejection over application 18/691,716 is not proper as the specific flavoring agents instantly recited are not claimed therein. This argument is not found persuasive as the newly cited reference Hall et al. addresses this limitation.
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 Brian Gulledge whose telephone number is (571) 270-5756. The examiner can normally be reached Monday - Friday 7am - 4pm.
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/Brian Gulledge/Primary Examiner, Art Unit 1699
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