DETAILED ACTION
Claims 1-12, submitted on December 5, 2023, are pending in the application and are rejected for the reasons set forth below. No claim is allowed.
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 . 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.
Claim Rejections – 35 USC § 112(a)
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the inven-tion, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the inven-tion.
Claims 1-12 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention. At least the following are new matter: “terpinolene present in 5-50% by mass” and “ocimene present in 2-25% by mass.” This application is a continuation under 35 U.S.C. 120 of two earlier-filed applications. Applicant may rebut this rejection by showing, by reference to specific page and line numbers in any of the earlier-filed applications, where this subject matter is disclosed. The examiner has attempted to do so, but cannot find written support for these two claim limitations in any earlier-filed application. See MPEP1 211.05 (sufficiency of disclosure in prior-filed 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 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, namely, a product of nature, without significantly more.
The present application “relates to compositions, and related methods, that comprise defined mixtures of terpenes that have a distinctive fragrance that mimics that of non-combusted plant products, intermediates, and related moieties,” wherein “each terpene is either purified from a natural source or is synthetic.” See applicant’s specification at p. 1 and 6, respectively. The claims at issue are drawn to a prepared composition comprising certain terpenes, including “terpinolene present in 5-50% by mass” and “ocimene present in 2-25% by mass.” See claim 1. Terpinolene and ocimene are “natural products.” Applicant’s spec. at p. 2. The dependent claims further specify that the composition includes other naturally occurring terpenes. The claimed compositions “mimic the fragrance of plant matter that is processed or dried” or otherwise “mimic a documents emotional response that is conferred by the processed or dried plant matter.” Spec. at p. 3. The claims therefore generally relate to compositions that involve products of nature. The “container” referred to in claims 11-12 does not distinguish the claimed subject matter from the product of nature. The following discussion outlines the law as applied by the Office when assessing patentability of products of nature, such as those of the instant claims.
First, the claimed invention must be to one of the four statutory categories. See 35 U.S.C. 101, which defines the four categories of invention that Congress deemed to be the appropriate subject matter of a patent: processes, machines, manufactures, and compositions of matter. Second, the claimed invention also must qualify as patent-eligible subject matter, i.e., the claim must not be directed to a judicial exception unless the claim as a whole includes additional limitations amounting to significantly more than the exception. The judicial exceptions (also called “judicially recognized exceptions” or simply “exceptions”) are subject matter that the courts have found to be outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas, laws of nature and natural phenomena, including products of nature. Here, the claims are clearly drawn to a composition of matter, so they are within the four categories of invention defined in § 101. Next, we must ask whether the claims are directed to a judicial exception.
The Supreme Court in Mayo laid out a framework for determining whether an applicant is seeking to patent a judicial exception itself, or a patent-eligible application of the judicial exception. The first part of the Mayo test is to determine whether the claims are directed to an abstract idea, a law of nature or a natural phenomenon, i.e., a judicial exception. If the claims are directed to a judicial exception, the second part of the Mayo test is to determine whether the claim recites additional elements that amount to significantly more than the judicial excep-tion. Therefore, the examiner applies the following two-prong test to determine whether the claims at issue are eligible under § 101: Prong One asks does the claim recite an abstract idea, law of nature, or natural phenomenon? In Prong One examiners evaluate whether the claim recites a judicial exception, i.e., whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim. If the claim recites a judicial exception, the claim requires further analysis in Prong Two. Prong Two asks does the claim recite additional elements that integrate the judicial exception into a practical application? In Prong Two, examiners evaluate whether the claim as a whole integrates the exception into a practical application of that excep-tion. If the additional elements in the claim integrate the recited exception into a practical application of the exception, then the claim is not directed to the judicial exception. See 2106 (patent subject matter eligibility).
The examiner’s answer to Prong One, whether the claims recite a judicial exception, is “yes.” As outlined above, the claims are drawn to compositions of terpinolene and ocimene, both of which are products of nature. The examiner’s answer to Prong two, whether the claims recite additional elements that integrate the judicial exception into a practical application, is “no.” At best, the claims appear to be directed to a composition of an isolated or purified natural product, or a semi-synthetic recapitulation or recreation thereof. The examiner therefore concludes that the claims are directed to a judicial exception, namely, a product of nature, and are therefore not eligible under § 101.
Claim Rejections – 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shafagha et al., Nat. Prod. Commun. 2011;6(2):275-76.
Shafagha discloses a prepared composition comprising 14.5% terpinolene and 6.3% ocimene, specifically, cis-beta-ocimene. The composition also included germacrene, among other terpenenes. It is implicit that the composition is in some sort of container.
Claim Rejections – 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 provides for terpinolene as ingredient “iii,” but this is outside the list of terpenes and terpenoids provides in item “iii” listed claim 1. That is, claim 4 is broader in scope than claim 1. Applicant may cancel the claim, amend it to place it in proper dependent form, rewrite it in independent form, or present a sufficient showing that it complies with the statutory requirements.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The examiner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). Exam-iner 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, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/ Primary Examiner, Art Unit 1628
March 31, 2026 (revised April 22, 2026)
1 Manual of Patent Examining Procedure (MPEP), Latest Revision November 2024 [R-01.2024]
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