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 .
Election/Restrictions
Claims 1-18 are pending in the instant application. Applicant’s election without traverse of Group II, Claims 5-18 in the reply filed on 10 December 2025 is acknowledged. Claims 1-4 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10 December 2025.
Claims 5-18 are being examined on the merits.
Specification
The disclosure is objected to because scientific names, including genus names alone, should be italicized throughout the document. In [0002]-[0003], for example, Rhodiola, Rhodiola rosea, and Rhodiola crenulate should be properly italicized. Appropriate correction is required.
Claim Objections
Claims 5-18 are objected to because scientific names should be italicized throughout. In Claims 5, 12, and 13, Rhodiola crenulata should be italicized. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 5 and 13 recite the steps “drying the [first or second] extraction fluid into a(n) [first or second] extraction powder.” As written, the method steps do not require extraction of, and instead merely require adding of, Rhodiola crenulata root into the extraction fluid. It is unclear whether the extraction fluid which is being dried comprises extractant from Rhodiola crenulate or not, and (in claim 13) whether the “extraction fluid,” refers to either the first, second, or another extraction fluid. For clarity, it is recommended that this limitation be rephrased to the following, or similar in accordance with the present disclosure:
extracting Rhodiola crenulata root with the extraction fluid to obtain a Rhodiola crenulata extract; and
drying the Rhodiola crenulata extract into a Rhodiola crenulata extract powder.
Claim 8 recites the limitation “the content level of other flavonoids.” There is insufficient antecedent basis for this limitation.
Claims 8, 9, 15, 16, and 18 recite the limitation “other flavonoids.” It is unclear what is meant by “other” flavonoids. If a content level of flavonoids is determined, it is unclear what “other” flavonoids are then being measured. Are these specific flavonoids, or is something else being referenced?
Claims 11 and 12 recite the limitation “water/ethanol.” It is unclear whether this phrasing refers to water or ethanol or a mixture of water and ethanol. The broadest reasonable interpretation would be “water or ethanol.” Claim 11 additionally recites “other alcohol combination” and it is unclear what this phrase refers to. What is the alcohol combined with? Additionally, the phrasing “selected from the group ‘comprising’ ” is indefinite, because it is unclear what other alternatives in the open-ended “comprising” list are intended to be encompassed by the claim (see MPEP 2173.05(h) and 2117).
Claim 12 is unclear because it states that a water/ethanol extract of Rhodiola crenulata is provided with the extraction fluid having a pH of 8.5. Is the extraction fluid added to the water/ethanol extract of Rhodiola crenulata? Or is the water/ethanol extraction fluid adjusted to a pH of 8.5 and then used to produce the water/ethanol extract of Rhodiola crenulata? As written, it is unclear what the intended meaning of the claim is.
Claim 16 is unclear because of the limitation “increasing an amount of salidrosides in the second extraction powder.” Since “increasing” is a relative term, the phrase must include what the amount is relative to. A higher amount relative to the first extraction powder? All other Rhodiola crenulata extracts? A specific extract of Rhodiola crenulata? Alternatively, a specific amount could be included in accordance with the present disclosure to help clarify this statement, e.g., “wherein the second extraction powder comprises at least 6 wt% salidrosides.”
Claims 9 and 16 are unclear because of the limitation “eliminating or nearly eliminating an amount of other flavonoids.” As previously stated, it is unclear what “other flavonoids” refers to, and it is additionally unclear what is meant by “eliminating an amount.” If there are 10 g of flavonoids in an extract, does that mean 10% are eliminated or “nearly” eliminated? Or 100%? What encompasses “nearly?”.
Appropriate clarification is required.
Claim Rejections - 35 USC § 102
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.
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 5-8 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chou et al. (US 8,119,170 B2).
The instant claims are as of record, drawn to a method of producing an extract of Rhodiola crenulata comprising the steps of providing an extraction fluid having a pH between 7.1 and 11, adding Rhodiola crenulata root to the extraction fluid, and drying the extraction fluid into a powder.
Chou et al., however, anticipate the claims by teaching a method for extracting Rhodiola crenulata comprising adding Rhodiola crenulata herb (root; see Chou et al., Abstract; as required for instant Claim 5 and 13) to 50% ethanol (extraction fluid having a pH between 7.1 and 11; first extraction fluid; second extraction fluid; as required for instant Claims 5, and 11-13) and performing reflux extraction to obtain a concentrated extraction paste which is then dried and ground into a powder (extraction powder; Chou et al., col. 12, lines 28-45; as required for instant Claims 5 and 13). Salidroside content and flavonoid content are measured via HPLC (Chou et al., col. 13; as required for instant Claims 6-8, 14, 17, and 18).
Claims 5 and 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Min et al. (CN 101974045 A, Translation, 12 pages).
The instant claims are as of record, drawn to a method of producing an extract of Rhodiola crenulata comprising the steps of providing an extraction fluid having a pH between 7.1 and 11, adding Rhodiola crenulata root to the extraction fluid, and drying the extraction fluid into a powder.
Min et al., however, anticipate the claims by teaching a method of preparing rhodioloside (salidroside) comprising adding Rhodiola crenulata root (Min et al., [0002]) to water (extraction fluid having a pH between 7.1 and 11; as required for instant Claims 5 and 11), extracting, filtering, and concentrating, and then performing a secondary alcohol precipitation in the concentrated solution, and drying the final product (powder; Min et al., Abstract, page 1; as required for instant Claim 5). The pH of the ethanol extraction fluid is adjusted to 8.0-10.0 using an alkali solution (Min et al., [0108]-[0109], page 8).
Claim Rejections - 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5-9, 11, and 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Chou et al. (US 8,119,170 B2) as applied to Claims 5-8 and 11 above, and further in view of Feng et al. (Chem Engin Process: Process Intens, Jan 2022, 11 pages).
The claims and teachings of Chou et al. are as of record.
Chou et al. do not teach eliminating or nearly eliminating an amount of flavonoids or subsequent extraction of the first extraction powder.
Feng et al. teach a fractionation method wherein salidroside is isolated (e.g., flavonoids other than salidroside are eliminated) from Rhodiola rosea crude extract. Crude extract powder was dissolved in water (first extraction fluid; extraction fluid having a pH between 7.1 and 11) During the second step of fractionation using n-butanol (second extraction fluid; other alcohol; extraction fluid having a pH between 7.1 and 11) as a solvent, 85.2% pure salidroside (increasing the amount of salidroside) was obtained (Feng et al., Abstract, page 1; as required for instant Claims 9, 13, 15, and 16).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the teachings of Chou et al. and Feng et al. to arrive at the instantly claimed invention. A skilled artisan would have a reasonable expectation of success at using the fractionation method of Feng et al. to provide higher purity salidroside from the crude Rhodiola crenulata extract of Chou et al. due to its strong extraction and separation ability (Feng et al., Abstract, page 1). Additionally, a skilled artisan would be motivated to do so because salidroside is non-toxic to humans, conforms to the life philosophy of modern humans, and is used in cosmetics and detergents (Feng et al., Introduction, page 1).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER L CAIN whose telephone number is (703)756-1318. The examiner can normally be reached M-Th 11:00am to 5:00pm EST.
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, Anand Desai can be reached at (571)272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655