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 .
Applicant’s amendment and response filed April 3, 2026 and April 21, 2026 has been received and entered.
Claim 1 is currently pending.
Election/Restrictions
Applicant’s election without traverse of Group I, claim(s) 1-2 in the reply filed on November 07, 2025 is acknowledged.
Claim 1 is examined on the merits.
Withdrawn Objections
Applicant’s arguments filed April 3, 2026 and April 21, 2026 has been fully considered. In regards to the objection of the specification for the incorrect spelling of “luteolun 7-glucuronide”, applicant has amended the specification to correct the spelling of “luteolin 7-glucuronide” and therefore, the objection of the specification has been withdrawn.
In regards to the objection of claim 1, applicant has amended the claim to correct the word “luteolun 7-glucuronide” to “luteolin 7-glucuronide” and therefore, the objection of claim 1 has been withdrawn.
Withdrawn Rejections
Applicant’s arguments filed April 3, 2026 and April 21, 2026 has been fully considered.
In regards to the rejection under 35 U.S.C. 112(b) for indefiniteness, applicant has elected to amend claim 1 and therefore, the rejection of claim 1 under 35 U.S.C. 112(b) has been withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, lines 16-17, “; or or characterized” should read “; or characterized”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 1 is 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.
Claim 1, at line 3, is indefinite because it is unclear what solvents are encompassed by “spirit”.
In addition, the recitation of “Korean native plant” at line 5 is indefinite. It is unclear if applicant is intending to limit the Agrimonia coreana to only plants that are grown or cultivated in Korea itself.
Moreover, the recitation of “conventional extraction” at line 7 is indefinite because it is unclear what extraction techniques are considered to be encompassed by “conventional”.
Furthermore, the recitation of “relative mixed weight ratio” at line 17 is indefinite because it is unclear what is considered to be “relative” compared to a “mixed weight ratio”. The specification does not list the exact meaning of the terms mentioned above. Thus, the metes and bounds of the claim are unclear.
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.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more. A composition comprising an Agrimonia coreana extract of claim 1 encompasses naturally occurring substances.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant's claims are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant's claims recite an extract from Agrimonia coreana which is a naturally occurring plant. Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that "When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A."
MPEP § 2106.04(c)(I) states that "if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states "The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product's structure, function, and/or other properties. . .".
In this case, extraction of plants only concentrates and portions the naturally occurring compounds in the plants which are soluble or insoluble in the particular solvent. General extraction does not necessarily result in a markedly distinct change in the naturally occurring compounds from the plant. Thus, while a solvent extract itself may not be found in the nature, the compounds which are present in the plant and soluble in the selected solvent are found in nature. The creation of a solvent extract only partitions and concentrates the molecules that are naturally in the plant. There is no evidence or reason to expect that any new compounds are formed. The extract itself is a mixture of the naturally occurring compounds that are simply soluble in a particular solvent. Thus, while extraction of the compounds with the selected solvent would separate a portion of the plant matter away from the naturally-occurring ingredients, the result of extraction is still a mixture of ingredients which are naturally-found in the plant material; i.e., the compound is not inventive or "man-made." Thus, the extract in turn is a mixture of the naturally occurring compounds found in the particular plants. The extract from the individual plant leads to a combination of the naturally occurring compounds from the plant. Thus, the claim is drawn to a mixture of naturally occurring products.
There is no indication that the specified extract as commensurate in scope with the stated claim changes the structure, function, or other properties of the extract in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart for the extract is a mixture of the naturally occurring compounds that are present in the extract. Because, as discussed above, the plant extract contains only a mixture of the naturally occurring compounds found in the plant. The extract composition appears to maintain its naturally occurring structure and properties and is merely present in the combination. In addition, there is nothing to show that mixing the ingredients in the particular concentrations produces any sort of marked distinction. Thus, the claimed mixture as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. In regards to product-by-process claims please note that MPEP § 2106.4(c)(I)( B) states “For a product-by-process claim (e.g., a claim to a cloned farm animal produced by a nuclear transfer cloning method), the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart…”. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant's claims are only directed to the extract itself and do not contain any additional elements. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by "Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself." In this case, the additional element in the claims is the presence of an extract. However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. Mixing specific compounds within the extract of A. coreana, such as luteolin 7-glucuronide, apigenin 7-glucuronide, quercetin, kaempferol as taught by Jeon (KR 2012090262 A - English translation provided) and luteolin, apigenin, quercetin, and kaempferol ([general]) derivatives as taught by Santos et al (Evidence-Based Complementary and Alternative Medicine, (Year: 2017), vol. 2017, pp. 1-13) does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
Response to Amendment
The declaration under 37 CFR 1.132 filed April 3, 2026 and April 21, 2026 are insufficient to overcome the rejection of claim 1 based upon the 35 U.S.C. 101 rejection for natural products as set forth in the last Office action because on pages 2-3 of the affidavit, applicant provides evidence that “the inventive extract of the present invention is superior to that of the cited document (D2)”. Based on the evidence provided within the affidavit that also corresponds to the specification of the present invention (pages 30-31 of the specification – with the exception that table 1 in the affidavits have a modification; instead of data for APH2O and AP30%, applicant substituted in data for AeI and AePF from the D2 reference), applicant has not provided convincing evidence solely off the premise that the data obtained in table 1 of the affidavit that for AeI and AePF from the D2 reference possess a “inhibition rate on T cell proliferation (%)” of 32.12 +/- 1.041% and 37.67 +/- 1.821%, respectively. However, it is unclear where within the D2 reference that the applicant acquired the data for sections AeI and AePF in table 1 of applicant’s affidavit due to the Santos et al reference not explicitly discussing how the extract from Agrimonia specifically affects T cell inhibition of proliferation. Moreover, given that table 1 was provided by applicant in the affidavit’s and within the specification, both tables show that APK200608 has a significant inhibition rate on T cell proliferation. However, one could argue that regardless of the type of genus and species used (e.g. Afrimonia coreana, Agrimonia eupatoria) that would still result in the presence of the same compounds of the present invention’s claims in which, would still result in a significant inhibition rate on T cell proliferation. All in all, the references provided by the examiner is only meant to establish that the ingredients that the applicant is claiming to be “inventive” has been shown to be known in the art prior to the effective filing date of the present invention.
Response to Arguments
Applicant’s arguments filed April 3, 2026 and April 21, 2026 has been fully considered and the arguments regarding the rejection under 35 U.S.C. 101 are found to be non-persuasive. Before delving into the 35 U.S.C. 101 rejection, examiner will note that based on the information provided within applicant’s arguments across pages 12-24, applicant should be aware that there were no prior art rejections under 35 U.S.C. 102 and 35 U.S.C. 103 and the two references provided within the 35 U.S.C. 101 rejection by Jeon and Santos et al were incorporated to show that the ingredients claimed by the applicant of the present invention were already known in the art prior to the effective filing date of the present invention. In addition, at the bottom of page 12 of applicant’s arguments, applicant state the presence of a newly found compound such as “alphitolic acid”; given that “alphitolic acid” is not stated within the claims of the present invention, this discovery of the compound will be rendered as moot by the examiner. Moreover, given that the applicant has created a product by process claim within the claim amendments dated April 21, 2026, the product as claimed is not limited to the method of making, see MPEP § 2106.4(c)(I)( B) and MPEP § 2113(I). Lastly, regarding applicant’s comment within applicant’s arguments on page 25, “the purified extract of the present invention does not fall under a judicial exception and the claimed composition has markedly different characteristics, and is not a “product of nature” exception. Thus, the claim is qualifies as eligible subject matter.” Based on the information provided by the applicant, examiner has reasons to believe that the claim does not qualify as eligible subject matter because the purified extract of the present invention does fall under a judicial exception and the claimed composition does not have markedly different characteristics because applicant has shown throughout the affidavit and applicant’s arguments that the extracts from different species under Agrimonia possess the same or similar compounds from that of the claims of the present invention that show that the compounds from an extract of Agrimonia coreana are already known in the art. Thus, applicant’s arguments are not persuasive and thus, the rejection under 35 U.S.C. 101 for natural products is maintained.
No claims are allowed.
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 Nashara L Moreau whose telephone number is (571)272-5804. The examiner can normally be reached Monday - Thursday, 8 AM - 4 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand U 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.
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NASHARA L MOREAUExaminer, Art Unit 1655
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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