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 .
Claim Rejections – 35 USC § 112
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: “myrcene present in 11-21% by mass” and “limonene present in 5-45% 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 “myrcene present in 11-21% by mass” and “limonene present in 5-45% by mass.” See claim 1. Myrcene and limonene 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 container referred to in claims 11-12 does not implicate any markedly different characteristics from the natural product itself. The claims therefore generally relate to compositions that involve products 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 myrcene and limonene, 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 § 102/103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 1-12 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US 2008/0193387 A1 by de Wolff.
De Wolff discloses compositions comprising myrcene, limonene, β-caryophyllene, linalool, and other terpenes or terpenoids (para. 0071). These ingredients are obtained from Lippia javanica (para. 0071), which is a natural source within the meaning of instant claim 3 and 8. These compositions are within a container (para. 0166-67), which meets the limitations of claims 11-12. The concentrations disclosed in the reference (see, e.g., para. 0098 and 0177) substantially overlap with the concentrations required by the instant claims. In situations like this, where the prior art seems to be identical to a claimed invention, it is Office policy to reject the claims under both § 102 and § 103. See MPEP 2112. The burden of explaining a patentable difference between de Wolff and the instant claims falls to applicant.
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
April 1, 2026 (revised April 24, 2026)
1 Manual of Patent Examining Procedure (MPEP), Latest Revision November 2024 [R-01.2024]