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
Applicant’s election of Group I in the reply filed on 10/23/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 10/23/2025.
Claims 1-14 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 1-14 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.
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.
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 1-3, 6-10 and 12-14 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) and 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).
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’sof8.52mg/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 in a composition.
Lau teaches “Results showed that 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”
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 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.").
Claims 4-5 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) and 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) as applied to claims 1-3, 6-10 and 12-14 above, and further in view of 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).
Liu, Abu-Reidah and Lau teach the instant botanical composition however are silent on the composition comprising plant extract from Chrysanthemum indicum, Camellia sinensis, Salvia miltiorrhiza, or a combination thereof.
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).
Therefore it would have been obvious to persons having skill in the art before the effective filing date to combine Chrysanthemum indicum in the botanical composition taught by Liu, Abu-Reidah and Lau for having both antiviral and antioxidant activity because it is prima facie obvious to combine equivalents known for the same purpose.
There would have been a reasonable expectation of success in arriving at the instant invention because the claims are merely directed to an oral botanical composition comprising the above listed components and the reasons to combine them are obvious to create a composition for having antiviral (SARS Covid specific) and antioxidant capacity.
Claim 11 is 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) and 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) as applied to claims 1-3, 6-10 and 12-14 above, and further in view of 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).
Liu, Abu-Reidah and Lau teach the instant botanical composition however are silent on the composition comprising Camellia sinensis.
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 Camellia sinensis in the botanical composition taught by Liu, Abu-Reidah and Lau for having antioxidant activity because it is prima facie obvious to combine equivalents known for the same purpose.
Conclusion
Currently no claims are allowed.
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.
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JACOB A BOECKELMAN Examiner, Art Unit 1655
/TERRY A MCKELVEY/ Supervisory Patent Examiner, Art Unit 1655