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 04/17/2026 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 Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1 and 6-20 are pending of which claims 15-20 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 10/23/2025.
Claims 1 and 6-14 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.
Claims 1 and 6-14 are rejected under 35 U.S.C. 101 because the claimed composition is directed to a product of nature without significantly more. The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since the claims are 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 claims state the nature-based products plant extracts from an Arum genera plant, Houttuynia cordata, and Scutellaria baicalensis, Chrysanthemum indicum, Camellia sinensis, Salvia miltiorrhiza or a combination thereof, 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. The claims further recite that the formulation can be in a form of a liquid, a granule, or a tincture and these limitations do not help overcome the rejection as these are natural forms that these judicial exceptions can be found existing. Tinctures are usually alcohol extractions of those components and granules are mere small crystalized forms, while any of the judicial exceptions can be found existing in liquids.
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 only further limits the species of plant or the type of extracting solvent used to extract the judicial exceptions. These limitations do not limit the composition to a physical manifestation of a specific 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 treating viral infections is also well-understood, routine, ordinary practice in the field as evidenced by at least the following documents: US5939072A, US5989556A, US20040253331A1, US20050129704A1 and US20070009622A1.
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 04/17/2026 have been fully considered but they are not persuasive. The applicant argues that the amendments overcome the rejection however the applicant has included formulation types that naturally occur or ones in which the judicial exceptions can be found naturally existing and so the claims stand rejected. It is advised to remove any naturally occurring formulations to overcome the rejection.
Claim Rejections - 35 USC § 103
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, 6-14 are rejected under 35 U.S.C. 103 as being unpatentable over Hongbo Liu et. al. (Scutellaria baicalensis extract and baicalein inhibit replication of SARS-CoV-2 and its 3C-like protease in vitro, Journal of Enzyme Inhibition and Medicinal Chemistry, Jan 4, 2021, Vol. 36, NO. 1, 497-503), Kit-Man Lau et. al. (Immunomodulatory and anti-SARS activities of Houttuynia cordata, Journal of Ethnopharmacology 118 (2018) 79-85), Ibrahim M. Abu-Reidah et. al. (Comprehensive metabolite profiling of Arum palaestinum (Araceae) leaves by using liquid chromatography–tandem mass spectrometry, Food Research International 70 (2015) 74-86), Fadia Youssef et. al. (Chrysanthemum indicum and Chrysanthemum morifolium: Chemical Composition of Their Essential Oils and Their Potential Use as Natural Preservatives with Antimicrobial and Antioxidant Activities, Foods, 2020, 9, 1460. 1-18) and Maram M. Aboulwafa et. al. (A Comprehensive Insight on the Health Benefits and Phytoconstituents of Camellia sinensis and Recent Approaches for Its Quality Control, Antioxidants 2019, 8, 455: 1-30). This rejection is newly formed with the previously relied on art to take into account the amendments filed on 04/17/2026.
Liu teaches that “We studied the anti-SARS-CoV-2 activity of S. baicalensis and its ingredients. We found that the ethanol extract of S. baicalensis and its major component, baicalein, inhibit SARS-CoV-2 3CLpro activity in vitro with IC50’s of 8.52mg/ml and 0.39 mM, respectively. Both of them inhibit the replication of SARS-CoV-2 in Vero cells with EC50’s of 0.74 mg/ml and 2.9 mM, respectively. While baicalein is mainly active at the viral post-entry stage, the ethanol extract also inhibits viral entry. We further identified four baicalein analogues from other herbs that inhibit SARS-CoV-2 3CLpro activity at mM concentration. All the active compounds and the S. baicalensis extract also inhibit the SARS-CoV 3CLpro, demonstrating their potential as broad-spectrum anti-coronavirus drugs” (see abstract).
Liu teaches extracting with 70% ethanol (see 2.2, page 498).
Liu does not teach Arum or Houttuynia cordata, Chrysanthemum indicum, Camellia sinensis, Salvia miltiorrhiza, or a combination thereof. in a composition.
Lau teaches “Results showed that Houttuynia cordata (HC) water extract could stimulate the proliferation of mouse splenic lymphocytes significantly and dose-dependently. By flow cytometry, it was revealed that HC increased the proportion of CD4+ and CD8+ T cells. Moreover, it caused a significant increase in the secretion of IL2 and IL-10 by mouse splenic lymphocytes. In the anti-viral aspect, HC exhibited significant inhibitory effects on SARS-CoV 3C-like protease (3CLpro) and RNA-dependent RNA polymerase (RdRp). On the other hand, oral acute toxicity test demonstrated that HC was non-toxic to laboratory animals following oral administration at 16g/kg. Conclusion: The results of this study provided scientific data to support the efficient and safe use of HC to combat SARS” (see abstract).
Abu-Reidah teaches “Arum palaestinum is a wild edible plant used in food and folk medicine within the Mediterranean region including Palestine. The leaves are traditionally consumed as anti-cancerous food. Yet, just few reports are available on its chemical composition. Therefore, in this work, an extensive qualitative identification via liquid chromatography tandem mass spectrometry (UHPLC–DAD-ESI-MS/MS) of the phytochemical metabolites in A. palaestinum leaves has been established. A total of 180 phytochemicals, mainly 53 flavonoids, 33 phenolic acids, 10 terpenoids, 7 iridoids and 6 amino acids have been characterized. Moreover, 11 unknown compounds were also detected, providing the first comprehensive characterization available on the phytochemical composition of the leaves of A. palaestinum, highlighting it as an abundant source of antioxidant phenolics and phytochemicals. The obtained results may develop the current knowledge on A. palaestinum, boost further research towards bioactive compounds exploring and may encourage more consumption of this important functional food”
Youssef teaches that the “this study provides evidence beyond the traditional use of both Chrysanthemum indicum and C. morifolium as anti-infective agents. Thus they could be used as spices in food and can be incorporated in different food products and pharmaceutical preparations as natural preservatives possessing antioxidant potential” and teaches specifically that the components found within the extracts have antiviral activity (see abstract).
Aboulwafa teaches that “Green tea is very popular because of its marked health benefits comprising its anticancer, anti-oxidant, and antimicrobial activities, as well as its effectiveness in reducing body weight. Additionally, it was recognized by Chinese people as an effective traditional drink required for the prophylaxis against many health ailments. This is due to the complex chemical composition of green tea, which comprises different classes of chemical compounds, such as polyphenols, alkaloids, proteins, minerals, vitamins, amino acids, and others” (see abstract).
“In traditional medicines, green tea is considered a reference drug for many plant species with respect to its anti-oxidant potency [18]. This activity is mainly attributed to its polyphenols that are represented by its flavanols, which can be readily oxidized to the corresponding o-quinones, and thus function as hydrogen acceptors, as well as hydrogen donors [19]. The interaction with reactive oxygen species could be accomplished by the polyphenolic compounds existing in green tea via possessing different degrees of free radical scavenging properties, particularly toward oxygen-free radicals [20] and to some extent toward nitrogen (NO) species’ production inhibition [21]. The linkage of flavan-3-ol to gallic acid (GA) and the O-trihydroxy structure in the B ring are important criteria for the O2 and NO scavenging activity of tea polyphenol [22]. Besides, green tea polyphenols possessing ortho-dihydroxyl functional groups, exemplified by epi-catechin and epi-catechin gallate, are good antioxidants that act in synergism with endogenous-tocopherol [23].” (see page 2, 2.1).
Therefore it would have been obvious to persons having skill in the art before the effective filing date to combine Arum genera plant, Houttuynia cordata, and Scutellaria baicalensis into a single oral botanical composition because as discussed, both Houttuynia cordata, and Scutellaria baicalensis have ant SARS-Covid activity and the Arum genera of plants, especially that of Arum palaestinum contain many phytochemicals and is an abundant source of antioxidants. Combining these into a single composition would have been obvious to create a composition which could protect and fight off SARS-Covid virus while having beneficial antioxidation activities. It would have been obvious to combine Chrysanthemum indicum and Cameilla sinensis in the botanical composition taught for having both antiviral and/or antioxidant activity because it is prima facie obvious to combine equivalents known for the same purpose.
It would have been obvious to use an alcoholic extract such as 70% ethanol because Liu teaches this as an extracting solvent. Optimizing to 20% ethanol is something any person having skill in the art can do without any undue experimentation, especially since this does not seem to be critical to the invention nor distinguishes it from the prior art. It would have also been obvious to optimize the extracts to be within the instantly claimed amounts and ratios as this is an optimization well within the purview of any skilled artisan. Additionally, In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
Response to Arguments
Applicant's arguments filed 04/17/2026 have been fully considered but they are not persuasive. The applicant argues that the have reported some evidence of unexpected results which is shown from combining Arum palaestinum, Houttuynia cordata, Scutellaria baicalensis, and Chrysanthemum indicum and based on the IC90 of each individual botanical extract as indicated in FIG. 3A at a ratio of 2:3:3:4. It is unclear where the ratio which is described in this argument is described in FIG. 3A. The amounts for the Arum palaestinum is 6.96 ug/ul, Houttuynia cordata is 17.94 ug/ul, Scutellaria baicalensis is 92.88 ug/ul and Chrysanthemum indicum is 100.16 ug/ul. These amounts are not the ratios being argued. The applicant argues that the expected IC90 compared to the observed IC90 at the 2:3:3:4 ratio is 5.5-fold lower than what was expected and so with such an increase in activity, synergy exists as this is more than the sum of what is expected. It is still unclear how the applicant has determined the ratio of 2:3:3:4. Even if this synergy is agreed upon after further clarification from the applicant, the applicant does not claim such amounts and so outside the observed potential synergy exists predictable formulations which are obvious as argued in the above rejection.
It is suggested to clarify on record how the applicant has determined the ratios for the claimed combined ingredients and to amend the claims to be in scope with the synergy noted along with the activity for what that synergy is directed to. This should help move the case forward to overcome the art.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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.
JACOB A BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655
Prosecution Insights