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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/18/2025 and 02/11/2026, are in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The IDS documents were considered. A signed copy of Form PTO-1449 is enclosed herewith.
Status of the Claims
Claims 1-2, 14, 17-18, 20 and 22 are pending.
Applicant’s arguments, filed 03/02/2026, have been fully considered. Rejections and/or objections not reiterated from previous Office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Applicants’ amendments, filed on 03/06/2026, have each been entered into the record. Applicants have amended claims 1, 14, 17, 20 and 22. Applicants have cancelled claims 3, 6, 9, 12,19 and 21. Therefore, claims 1-2, 14, 17-18, 20 and 22 are subject of the Office action below.
Withdrawn Rejections:
The rejection of claims 3, 6, 9, 12 and 19-22 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is overcome by the Applicants’ amendments and is hereby withdrawn. For example, claims 3, 6, 9, 12, 19 and 21 have been cancelled. Claims 20 and 22 have been amended to correct the indefiniteness.
The rejection of claims 1-3, 6, 9, 12, 14 and 17-22 under:
1) 35 U.S.C. 102(a)(1) as being anticipated by Edward of record (World J. Pharmacy & Pharmaceutical Sciences, 2014); and
2) 35 U.S.C. 103 as being unpatentable over Edward of record (World J. Pharmacy & Pharmaceutical Sciences, 2014),
is overcome by the Applicants’ amendments and is hereby withdrawn. For example, claims 1 and 17 have been amended to introduce the limitation of a composition comprising:
i) cedrol, β-sitosterol and linoleic acid; or
ii) ferulic acid, β-sitosterol and linoleic acid.
Response to Applicants’ Arguments/Remarks
Applicants’ arguments (see pages 4-13 of Remarks filed on 03/02/2026), have been fully considered, but they are rendered moot in view of the Applicants’ amendments. For example, Applicants’ amendment of claims 1 and 17 (see discussions above) and cancellation of claims 3, 6, 9, 12, 19 and 21, necessitates new grounds of rejection set forth below in the instant rejection.
Claim Rejections - 35 USC § 101
New Grounds of Rejection Necessitated by Applicants’ Amendments
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 1-2 and 14 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.
Making reference to the Interim Guidance for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature in view of Mayo Collaborative Services v. Prometheus Laboratories, Inc. 566U.S._132 S.Ct. 1289, 101 USPQ2d 1961 (2012), the Supreme Court made clear that claims that do nothing significantly more than simply describing natural relations are not patentable. For instance, the Supreme Court stated:
“If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself. A patent, for example, could not simply recite a law of nature and then add the instruction "apply the law." Einstein, we assume, could not have patented his famous law by claiming a process consisting of simply telling linear accelerator operators to refer to the law to determine how much energy an amount of mass has produced (or vice versa). Nor could Archimedes have secured a patent for his famous principle of flotation by claiming a process consisting of simply telling boat builders to refer to that principle in order to determine whether an object will float…
To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities.”
In the instant case, the claims are held to be directed to a law of nature, a natural phenomenon, or naturally occurring relation or correlation without significantly more, and are therefore rejected as ineligible subject matter under 35 U.S.C. 101. The rationale for this finding is explained below:
The claim(s) recite(s) a composition comprising cedrol, β-sitosterol and linoleic acid.
Based upon an analysis with respect to the claims as a whole, claim 1 is determined to be directed to a law of nature/natural principle. The rationale for this determination is explained below.
1) Is the claimed invention directed to at least one of the four statutory categories (process, machine, manufacture or composition of matter)?
Claim 1 is directed to a composition, specifically a composition comprising cedrol, β-sitosterol and linoleic acid. As such, the condition for the first inquiry is met.
2A) Does the claim recite or involve a judicial exception (Abstract Ideas, Laws of Nature/Natural Principles, Natural Phenomena or Natural Products)?
Claim 1 recites naturally occurring cedrol, β-sitosterol and linoleic acid. For example, Wajs-Bonikowska et al (NPC, 2013, 8(9), 1297-1300), teaches cedrol, β-sitosterol and linoleic acid, naturally occurring in Abies koreana (see abstract, page 1300 and Tables 1-2). As such, the condition for the second inquiry is met.
2B) Does the claim include additional elements/steps or a combination of elements/step that integrate the natural principle into the claimed invention such that the natural principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself? (Is it more than a law of nature plus the general instruction to simply “apply it”?).
No. This is because the claimed naturally occurring compounds are not markedly different from their naturally occurring counterparts, i.e., the individual naturally occurring compounds or their natural presence together in, for example, Abies koreana. There is no indication on the record that the mixture has any characteristics that are different from the naturally occurring compounds or their natural presence together. For example, the structures of each of cedrol, β-sitosterol and linoleic acid in the mixture has not been changed by their aggregation into a mixture and each compound in the mixture continues to have the same physical and/or biological properties it has individually. This judicial exception is not integrated into a practical application because the claims do not apply the claimed composition to any application.
Claim Rejections - 35 USC § 102
New Grounds of Rejection Necessitated by Applicants’ Amendments
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 1-2 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wajs-Bonikowska et al (hereinafter “Wajs-Bonikowska”, NPC, 2013, 8(9), 1297-1300).
Independent claim 1 is drawn to a composition comprising: i) cedrol, β-sitosterol and linoleic acid; or ii) ferulic acid, β-sitosterol and linoleic acid.
Regarding claim 1, Wajs-Bonikowska teaches a composition comprising cedrol, β-sitosterol and linoleic acid, in essential oils from Abies koreana (see abstract, page 1300 and Tables 1-2).
Regarding claim 2, Wajs-Bonikowska discloses that Abies koreana has been used to treat colds, stomach aches, vascular, indigestion and pulmonary diseases in folk medicine (see page 1297).
Regarding claim 14, the recited intended use of a composition of claim 1 (e.g., for improving skin), is an inherent property of the composition. Any properties exhibited by or benefits provided by the composition are inherent and are not given patentable weight over the prior art. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties Applicants disclose and/or claim are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. In the instant case, Wajs-Bonikowska teaches a composition of claim 1 (see discussions above).
Applicants are further requested to note that it is well settled that “intended use” of a composition or product, e.g., a composition comprising cedrol and linoleic acid, will not further limit claims drawn to a composition or product. See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In re Hack 114,
Therefore, claims 1-2 and 14 are anticipated by Wajs-Bonikowska.
Claim Rejections - 35 USC § 103
New Grounds of Rejection Necessitated by Applicants’ Amendments
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 17-18, 20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Wajs-Bonikowska (NPC, 2013, 8(9), 1297-1300) in view of Yoon et al (hereinafter “Yoon”, Lipids, 2009, 44, 471-476).
Similar to claims 17-18, Wajs-Bonikowska (see abstract, page 1300 and Tables 1-2), teaches a composition comprising cedrol, β-sitosterol and linoleic acid, in essential oils from Abies koreana. Abies koreana has been used to treat colds, stomach aches, vascular, indigestion and pulmonary diseases in folk medicine (see page 1297).
Although Wajs-Bonikowska is not explicit in teaching a method for improving skin, a person skilled in the art would have had a reasonable expectation of success in improving skin with essential oils from Abies koreana. This is because at the time of the instant invention, it was known in the art that essential oils from Abies koreana can be used for improving skin. For example, Yoon teaches a method for inhibiting the growth of acne causing bacteria, with a composition comprising essential oils from Abies koreana, and thereby promoting skin health (see abstract and discussions therein).
Accordingly, at the time of the instant invention, one skilled in the art would have envisaged a method for improving skin with a composition comprising cedrol, β-sitosterol and linoleic acid, in the disclosures of Wajs-Bonikowska and Yoon. A person skill in the art would have had a reasonable expectation that the administration of the composition to a patient in need thereof, would improve the skin of the patient.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
Therefore, claims 17-18 are obvious over Wajs-Bonikowska and Yoon.
Regarding claims 20 and 22, each of the limitation: i) “wherein the method has a free radical scavenging effect” (claim 20); and ii) “wherein the method has a hyaluronic acid synthesis promoting effect” (claim 22), is a property of a method of claim 17. Since Wajs-Bonikowska and Yoon combine to teach a method of claim 17 (see discussions above), the method of Wajs-Bonikowska and Yoon must necessarily exhibit the same properties of recited in claims 20 and 22.
An inherent characteristic may “be part of the prior art in an obviousness analysis even if the inherent characteristic was unrecognized or unappreciated by a skilled artisan.” Endo Pharm. Sols., Inc. v. Custopharm Inc., 894 F.3d 1374, 1381 (Fed. Cir. 2018).
Therefore, claims 20 and 22 are obvious over Wajs-Bonikowska and Yoon.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited references.
Conclusion
No claim is allowable.
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.
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Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/ Supervisory Patent Examiner, Art Unit 1629
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