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 .
Response to Amendment
Applicant's amendment and argument filed 03/05/2026 in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-3, 5-20 are pending of which claims 7-20 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/15/2025.
Claims 1-3 and 5-6 are being examined on the merits.
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.
This rejection is maintained due to the arguments and amendments filed on 03/05/2026. Claims 1-3 and 5-6 rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claims recite an herbal composition comprising an extract of Ohwia caudata or Anismeles indica and additionally Artemisia argyi, Ophiopogon japonicus, Houttuynia cordata, Platycodon grandifloras, Glycyrrhiza uralensis, Perilla frutescens and chrysanthemum. The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since the claim is directed to a composition comprising plant components the claim is a composition of matter. Step 2A prong one of the analyses evaluates whether the claim is a judicial exception (see MPEP 2106.04). Because the claim states the nature-based products Ohwia caudata or Anismeles indica and additionally Artemisia argyi, Ophiopogon japonicus, Houttuynia cordata, Platycodon grandifloras, Glycyrrhiza uralensis, Perilla frutescens and chrysanthemum, the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterpart.
The claim recites the naturally occurring components found within plants. Plant extracts are made by partitioning the starting plant material into separate compositions based upon some property such as solubility in a solvent, with the soluble compounds being in one composition and the insoluble being in another composition, which compositions are then generally separated into the solvent extract of that plant versus the insoluble material composition that is generally discarded. Each composition has a different subset of the compounds originally present in the plant material. Plant extracts are purified by removing unwanted plant material from the remaining solvents. The closest naturally occurring counterparts of extracts are the same compounds found within the extract that are found in the plant in an unseparated form, even when purified, which is chemically identical to the extracted compounds. All of these are naturally occurring in nature and are not markedly different from its naturally occurring counterpart in its natural state. The properties of the nature-based product as claimed are not markedly different than the properties of these naturally occurring counterparts found in nature as these activities would inherently be found within the plants they come from. The components which would give the activities claimed in the instant invention would inherently do the same in nature as there has been nothing done in the instant invention that would make them act in any different way.
Step 2A prong two evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a) identifying whether there are any additional recited elements in the claim beyond the judicial exception and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. This judicial exception is not integrated into a practical application because the applicant is merely claiming the judicial exceptions in particular ratios (see claims 5-6), different components of the plant that are to be extracted from (see claim 2) or an intended use of the composition containing those judicial exceptions (see claim1). None of these limitations incorporate the judicial exceptions into any practical application. Doing so would be implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b).
The claims do not integrate the judicial exceptions into a practical application because in this context, such integration for a claimed product would be a physical form of the specific practical application instead of a more general composition that is not so limited.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these components and their activity are already found naturally occurring in nature and the addition of an intended use does not impart any added benefit to the compounds or integrate the composition into a practical application.
Step 2 B evaluates whether the claim as a whole, amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (see MPEP § 2106.05(b)).
Since the naturally-occurring components as-claimed are not found together in nature, admixing the ingredients into a single formulation is considered an ‘additional element’ which must be analyzed for eligibility. Admixing naturally-occurring plant extracts is well-understood, routine practice in the art and has been conducted for centuries. Admixing plant extracts for creating compositions for treating a viral infection is also well-understood, routine, ordinary practice in the field as evidenced by at least the following documents: (US 5989556 A), (US 6214350 B1), (US 20040253331 A1), (US 20080152735 A1) and (US 20160158300 A1).
Please also note, the mere modifying the concentration and proportions of the product/composition is not sufficient to remove the claimed composition from a judicial exception.
Therefore, admixing the claimed naturally-occurring ingredients at such a high degree of generality merely involves applying the natural principal and appears to be no more than a drafting effort to claim the judicial exception itself; a mixture of naturally-occurring components that is not markedly different from its’ closest-occurring natural counterpart and which does not offer significantly more than the judicial exception.
Response to Arguments
Applicant's arguments filed 03/05/2026 have been fully considered but they are not persuasive. The applicant argues that claimed invention is directed to specific herbal composition for treating a viral infection caused by a coronavirus comprising an extract from an herbal raw material and a pharmaceutically acceptable carrier, wherein the extract comprises Ohwia caudata and is a water or an ethanol extract. The applicant believes that because it is a water or ethanol extract and that the claims recite a pharmaceutically acceptable carrier for a specific therapeutic use the claims are no longer directed to a naturally occurring product. The claims recite naturally occurring judicial exceptions which are the water and/or ethanol soluble compounds found within Ohwia caudata. A carrier so broadly claimed can be water which is found existing in nature and indeed with water soluble compounds from Ohwia caudata.
The applicant describes preparation examples which give detailed disclosure of herbal compositions including water and ethanol extracts of Ohwia caudatan, and describes experimental results which they believe gives evidence to a specific concrete therapeutic application of the composition rather than mere observation of a natural phenomenon. The rejection is based on the words of the claims and not the interpretation interpreted from reading the specifications. Additionally, the preamble merely recites an intended use for the claimed judicial exceptions and does not structurally change those judicial exceptions or impart some specific application of those judicial exceptions. Doing so would be implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b).
Claim Rejections - 35 USC § 103
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:
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Kwon Eun Bin et. al. (from IDS, "Protective Effect of Flavonoids from Ohwia caudata against Influenza a Virus Infection", Molecules, vol. 25, no. 19, 24 September 2020 (2020-09-24)) and Jaisa Oliveira Chaves et. al. (Extraction of Flavonoids from Natural Sources Using Modern Techniques, Frontiers in Chemistry, Vol 8, Article 507887, 1-25, 25 September 2020). This rejection is maintained with slight modifications due to the amendments filed on 03/05/2026.
Kwon teaches “To identify new potential anti-influenza compounds, we isolated six flavonoids, 2-hydroxyl yokovanol (1), 2-hydroxyl neophellamuretin (2), yokovanol (3), swertisin (4), spinosin (5), and 7-methyl-apigenin-6-C--glucopyranosyl 2”-O--d-xylopyranoside (6) from MeOH extractions of Ohwia caudata. We screened these compounds for antiviral activity using green fluorescent protein (GFP)-expressing H1N1 (A/PR/8/34) influenza A-infected RAW 264.7 cells. Compounds 1 and 3 exhibited significant inhibitory effects against influenza A viral infection in co-treatment conditions. In addition, compounds 1 and 3 reduced viral protein levels, including M1, M2, HA, and neuraminidase (NA), and suppressed neuraminidase (NA) activity in RAW 264.7 cells. These findings demonstrated that 2-hydroxyl yokovanol and yokovanol, isolated from O. caudate, inhibit influenza A virus by suppressing NA activity. The moderate inhibitory activities of these flavonoids against influenza A virus suggest that they may be developed as novel anti-influenza drugs in the future” (see abstract). Kwon teaches using the leaves and stems of O. caudate (see last para. of introduction).
Kwon does not teach using a water or ethanol extract as claimed.
Chaves’ general disclosure is to extraction techniques for flavonoids (see abstract).
Chaves teaches “In general, organic solvents (methanol, ethanol, acetonitrile, petroleum ether, acetone), water, and mixtures of these solvents are used for the removal of flavonoids from plant matrices, such as herbs, industrial residues, stems or plant seeds. Organic solvents such as ethanol, methanol, acetone, and isopropanol, mixed with varying proportions of water, have been widely used to extract flavonoids from plant sources using UAE. There are extractions with 100% of either organic solvent or water used for extraction” (see page 4 last para.).
Several studies have shown that due to the polarity of flavonoids, organic solvents, such as methanol, are more efficient for their extraction. Non-toxic and biodegradable alternatives, such as ethanol, are being explored to some extent in extraction methods to reduce the impact of organic solvents on the environment while providing similar, or even superior performance (Fu et al., 2019) (see first para., page 5).
The most used solvents for the extraction of flavonoids are ethanol, mixtures with water at different proportions, and natural deep eutectic solvents (NADES), which are based on their ability to solubilize moderately polar flavonoids with a relatively low cost and environmental impact” (see last para page 6).
“The polarity of the solvent and the solubility of the targeted compound in the solvent must also be considered. There is no standardized solvent composition for all since it is difficult to establish general rules, so the best solvent varies with each targeted compound (Xiang and Wu, 2017). In general, the solvent most used for polar flavonoids extraction is a mixture of water and organic solvents. Within these, methanol is highly toxic and is not practical for use in the processing of food and pharmaceutical products. It is generally used in analytical applications in different proportions depending on the compounds to be extracted (Chen et al., 2008). The most commonly used is ethanol, as it is a green solvent with low toxicity. As mentioned above, adding a certain amount of water to the ethanol solvent has been shown to improve extraction efficiency” (see first para., page 9).
Chaves also teaches that “Bioactive flavonoids are mainly present in edible parts but can also be present in other non-edible parts of the plants, including leaves, stem, and root” (see page 12, right column 2nd para.).
Therefore it would have been obvious to person having ordinary skill in the art and before the effective filing date to use water and/or ethanol as an extracting solvent for extraction of the flavonoids from Kwon’s teaching because it is a greener solvent that is not toxic and can extract out similarly polar flavonoids as methanol. It is known to those skilled in the art that solvent selection is an optimizable parameter as discussed by Chaves. Thus this optimization is well within the purview of any skilled artisan and one that is prima facie obvious.
Claims 3 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Kwon Eun Bin et. al. ("Protective Effect of Flavonoids from Ohwia caudata against Influenza a Virus Infection", Molecules, vol. 25, no. 19, 24 September 2020 (2020-09-24)) and Jaisa Oliveira Chaves et. al. (Extraction of Flavonoids from Natural Sources Using Modern Techniques, Frontiers in Chemistry, Vol 8, Article 507887, 1-25, 25 September 2020) as applied to claims 1-2 above, and further in view of Chen Jia-yi and Li Jiashu (CN111358822A). This is a new rejection due to the arguments and amendments filed on 03/05/2026.
Kwong and Chavez’s combined art teaches the instant composition however are silent on the composition having one of the additional raw components of claim 3.
Jia-yi teaches of wild chrysanthemum flower extract which can kill novel coronavirus SARS-CoV-2 (see page 5, example 5).
Therefore it would have been obvious to person having ordinary skill in the art and before the effective filing date to add chrysanthemum in the composition taught by Kwong and Chaves in order to create an anti-viral composition that can target both influenza and SARS-CoV viruses. It would have been obvious to optimize the amount of the raw material to be within the claimed ranges as these are mere optimizations of any skilled artisan for finding optimal efficacies in activity and for finding the least off target activities. The amounts do not appear critical to the claimed invention and therefore would have been arrived upon by those having ordinary skill in the art.
Response to Arguments
Applicant's arguments filed 03/05/2026 have been fully considered but they are not persuasive. The applicant argues that Kwon is silent on the extract being a water or ethanol extract. The Office utilizes Chaves to teach why it would have been obvious to substitute either ethanol or water as a solvent for extracting flavonoids from plants because it is a greener choice and isn’t toxic and can extract similarly polar compounds as methanol.
The applicant argues that Kwon is directed to treating influenza A virus and not to a coronavirus as amended. In response to applicant's argument that the prior art does not teach the use of the extract for treating a coronavirus, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case the broadly claimed Ohwia caudata water or ethanol extract would meet the claim limitations and therefore the instant application is not patentably distinct from the combined prior art.
The applicant argues that the person having ordinary skill in the art would not be motivated by Kwon and Chaves to create a composition comprising a water or ethanol extract of Ohwia caudata for treating a coronavirus. A person having ordinary skill given the prior art would arrive at the instant claims as both ethanol and water are described as more suitable solvents for extracting flavonoids from plants as described by Chaves. The motivation to substitute either solvent does not have to be for creating a composition for treating coronavirus as argued. The motivation can be different than that of the applicants. The preamble reciting that the herbal composition is for preventing or treating a viral infection caused by a coronavirus is an intended use and does not structurally change the claimed composition.
The applicant argues that Hong does not teach the Ohwia caudata extract as claimed. The Office does not rely on Hong for teaching a Ohwia caudata extract because Kwon already teaches this component. The Office no longer relies on Hong to teach the chrysanthemum and relies upon Jia-yi to teach why it would have been obvious to combine chrysanthemum with the invention taught by Kwon and Chaves for creating an antiviral composition for treating both influenza and coronavirus.
Conclusion
Currently no claims are allowed.
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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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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