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 .
Current Status
This action is responsive to the amended claims of 02/12/2026. Claims 1-11, 13-18, and 27-30 are pending. Claims 27-30 are new. Claims 1-10 and 13-18 have been withdrawn. Claims 11 and 27-30 have been examined on the merits.
Election/Restrictions
Applicant’s election of Group II (claims 11 and 27-30) election of the following species: 1) a pharmaceutical extract comprising Andrographis paniculata, Eriobotrya japonica, and Reynoutria japonica; and 2) remdesivir, in the reply filed on 02/12/2026 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)).
A search for the elected species retrieved prior art (see SEARCH 6 of the attached search notes). Therefore, per Markush search practice, the Markush search will not be extended unnecessarily to additional species in this Office Action.
The elected species read on claims 11 and 27-30.
Claim 1-10 and 13-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (Groups I & III), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/12/2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The effective filing date is 09/28/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/28/2023, 04/09/2025, and 02/12/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 29 is objected to because of the following informalities: Examiner believes the following word are misspelled: 1) “ritinovir” should be “ritonavir” and 2) “shikonon” should be “shikonin”. Appropriate correction is required.
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 11 and 27-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a phenomenon of nature (natural products) without significantly more. The claims recite a composition comprising extracts of Andrographis paniculata, Eriobotrya japonica, and Reynoutria japonica and further antiviral agents chosen from multiple other natural products (e.g., curcumin). This judicial exception (JE) is not integrated into a practical application because the claims do not recite any further limitations which would apply the composition, e.g., affecting treatment of a disease. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because it is well-understood, routine, and conventional in the art to 1) extract chemical compounds from the recited plants and 2) mix pharmaceutically active compounds together to produce dosage forms.
Step 1: Is the claim drawn to a process, machine, manufacture, or composition of
matter?
Yes, the broadest reasonable interpretation (BRI) of the claims as a whole are
drawn to a composition of matter comprising extracts of Andrographis paniculata, Eriobotrya japonica, and Reynoutria japonica and further antiviral agents chosen from multiple other natural products (e.g., curcumin).
Revised Step 2A:
Prong One: Does the claim recite an abstract idea, law of nature, or natural
phenomenon?
Yes, the claims are drawn to a natural phenomenon – extracts of Andrographis paniculata, Eriobotrya japonica, and Reynoutria japonica. The instant specification admits Andrographis paniculata, known as creat or green chiretta, is an herbaceous plant native to India and Sri Lanka (Pg. 6 Lines 14-15). Further, the instant specification states multiple different compounds including andrographolide, ursolic acid, and piceid can be extracted from/found in various plants including Andrographis paniculata, Eriobotrya japonica, and Reynoutria japonica.
The claimed extracts of these plants are not markedly different from their natural counterpart – the mixture of compounds that exists naturally within the plants. The chemical and physical properties of said compounds have not been changed by the extraction process, e.g., the chemical structures of the compounds are not changed by extraction. Further, instant claim 11, under the BRI, encompasses compositions wherein the extracts are mixed together or kept apart. In the case of mixing to form the composition, the simple mixing of three extracts comprising natural products does not change the chemical structure and physical properties of said natural products.
The further antiviral agents recited in instant claim 29 are chosen from multiple other natural products: heparin, zinc, quercetin, glycyrrhizin, baicalin, patchouli alcohol, luteolin, hesperidin, emodin, kaempferol, lignin, betulinic acid, tanshinone, cryptotanshinone, dihydrotanshinone, tanshinone IIA, curcumin, shikonon (shikonin), and matrine. Many of these compounds are listed as natural compounds in Table 2 (Pg. 6) of evidentiary reference HUANG (Huang, F. et al., Pharmacological Research, 20 May 2020, 158, 1-12; cited in IDS of 04/09/2025).
The addition of further therapeutic/antiviral agents, comprising other natural products, to the pharmaceutical composition does not structurally or chemically alter the chemical compounds of the extracts recited in instant claim 11 (e.g., curcumin is not reacted with andrographolide to produce a new compound). The simple mixing of multiple natural products does not make any one of those natural products any less natural. Thus, the natural products are found to not be markedly different from their natural counterparts. Further, while instant claim 29 recites antiviral agents which are not natural products, simple mixing of a natural product (i.e., the extracts of claim 11) and a non-natural drug does not alter the natural products themselves (e.g., remdesivir is not reacted with andrographolide to produce a new compound). Thus, the claimed extracts are not found to be markedly different.
Prong Two: Does the Claim Recite Additional Elements that Integrate the Judicial Exception (JE) into a Practical Application?
No, the BRI of claims 11 and 27-30 contain no additional elements which would integrate the JE into practical applications. The claims are drawn to a composition of matter. The claims do not recite any uses for the composition of matter nor any method steps for use of the claimed composition, such as application to effect a particular treatment for a disease (see MPEP 2106.04(d)(I)). At most, the formulation of the natural extracts into a pharmaceutical composition (claim 11) formulated for oral administration (claim 30) is a suggestion to “apply it” to the field of medicine (see MPEP 2106.05(f)). This, however, does not rise to the level of practical application.
Further, the addition of further therapeutic agents (claims 27-29), including other natural products discussed above, does not provide a practical application, but a further suggestion to “apply it”. The addition of a further therapeutic agent, natural or unnatural, does not implement or use the JE in conjunction with a particular manufacture (i.e., additional drug) since the claim does not actually recite any use/method steps.
Step 2B: Does the claim recite additional elements that amount to significantly more than the JE?
No, the BRI of the claims does not recite additional elements amounting to significantly more.
First, it is well-understood, routine, and conventional (WURC) in the art to extract chemical compounds from plants. As evidenced by ZHANG (CN 105833034, pub. 2016; translation attached) and SUN (CN 103611028, pub. 2014; translation attached), extraction of compounds from plants including the 3 instantly recited plants is a known technique: ZHANG (Pg. 16 ¶25) and SUN (Pg. 40-41 ¶82-84) both recite boiling the medicinal plants in water to decoct, i.e., extract chemical components from the plants. Thus, the extraction of these plants is WURC.
Further, these extracts are known to have medicinal value as antiviral agents: SUN discloses the decoction is effective in treating pneumonia (Pg. 42 ¶85); HUANG (cited above) discloses andrographolide, the main active component isolated from Andrographis paniculata, has anti-virus biological activity (Pg. 5 sect 4.2) and resveratrol has antiviral activity (Pg. 6 Table 2). XIU (Xiu et al., Appl. Mircobiol. Biotechnol., 2007, 75, 763-768; provided by Examiner 11/12/2025) further recites resveratrol is produced by Polygonum cuspidatum (Pg. 763 Introduction ¶1), i.e., Reynoutria japonica.
Second, it is WURC in the art to formulate pharmaceutically active compounds into a pharmaceutical composition, including those for oral administration. Evidentiary reference CHAUDHARI (Chaudhari, S.P. & Patil, P.S., Internation Journal of Advances in Pharmacy, Biology, and Chemistry, 2012, 1(1), 21-34) provides a general review of standardization and safety evaluation procedures used in preparation of pharmaceutical dosage forms (Pg. 28-33 Tables 1-9). CHAUDHARI provides further guidance for formulation of oral dosage forms (Pg. 23 final ¶ - Pg. 24 left col.). Moreover, ZHANG (CN 105833034, pub. 2016; translation attached), provides support for the combination of extracts from the instantly recited plants (Pg. 15 ¶24) and formulation thereof into an oral dosage form (Pg. 20 ¶34). Thus, the formulation of such extracts into a pharmaceutical composition is WURC.
Third, the addition of further active agents, known to have similar therapeutic use is also WURC in the art. HUANG (cited above) provides a general review of evidence showing that antiviral agents, both natural and nonnatural, recited in instant claim 29 are known to have antiviral properties (Pg. 4-7 Tables 1 & 2). As evidenced by KOIZUMI (Koizumi, Y. & Iwami, S., Theoretical Biology and Medical Modeling, 2014, 11, 1-9), in the current era of antiviral drug therapy, combining multiple drugs is a primary approach for improving antiviral effects, reducing doses, and relieving side effects of said drugs, and preventing emergence of drug-resistant viruses (Pg. 1 Abstract). Thus, combination of medicinal agents having antiviral activity would be considered WURC in the art.
Note, while claim 11 also provides for specific amounts of the JE in the composition, having more or less of a natural product does not suddenly make the natural product more than just that. At most, a specified amount in a WURC dosage form merely provides a suggestion to apply the composition to the field of medicine. Moreover, the additional therapeutic/antiviral agents of claim 29 are recited in the alternative, thus, the claim only requires one of the many known agents be added to the composition. The composition is considered as WURC.
Thus, the additional elements of recited in the claims are understood as WURC techniques and cannot amount to significantly more than the JE.
Therefore, claims 11 and 27-30 are rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
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.
Claim 29 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 29 recites a series of additional antiviral agents; however, in the second to last line one of the antiviral agents is listed as “I”. No structure or chemical name for “I” is provided. It is unclear what compound “I” is meant to invoke. Thus, the metes and bounds of the claim are undefined rendering the claim indefinite.
Note: it appears this may be a typographical error. Did Applicant mean to recite “dihydrotanshinone I”? As currently drafted, there is a comma separating dihydrotanshinone and I.
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 11 and 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over:
SUN (CN 103611028, pub. 2014; translation attached),
as evidenced by
DOI (Department of Interior, Invasive Species Compendium: Japanese Knotweed Datasheet, 2010, retrieved from www.doi.gov/sites/doi.gov/files/migrated/invasivespecies/isac/2010/upload/ISC_Japanese_Knotweed_datasheet.pdf),
CHO (Cho et al., Evidenced-Based Complementary and Alternative Medicine, 2016, 2016, 1-9; provided by Examiner 11/12/2025), and
MAMEDOV (Mamedov, N. & Egamberdieva, D., Plant and Human Health, 2019, Vol. 3, 1-21),
in view of
ANSEL (Ansel, H.C. et al. Pharmaceutical Dosage Forms and Drug Delivery Systems, Lippincott Williams & Wilkins, 7th ed., 1999, pages 48-53),
and further in view of
HUANG (Huang, F. et al., Pharmacological Research, 20 May 2020, 158, 1-12; cited in IDS of 04/09/2025).
Note, a machine translation of SUN is referenced below and is provided by examiner.
Determining the Scope and Contents of the Prior Art:
SUN teaches a combination of traditional Chinese medicine for treating pneumonia (Pg. 5 ¶8). SUN teaches the medicine is a combination of medicinal herbs including Polygonum cuspidatum, Andrographis paniculata, and Eriobotrya japonica and other botanicals such as licorice (Pg. 6 ¶10). SUN teaches the dosages of the drugs in the combination is as follows: Polygonum cuspidatum 6-16 g (Pg. 16 ¶14), Andrographis paniculata 8-16 g (Pg. 16 ¶16), Eriobotrya japonica 8-16 g (Pg. 17 ¶17; note, the plant is referred to as loquat in this paragraph). SUN further provides weight for each of the other medicinal herbs of the composition (Pg. 15 ¶13 – Pg. 19 ¶25). SUN teaches the medicine is made by adding the herbs to 8x water and decocting (i.e., extracting) boiling/simmering for 35 minutes and then adding 6x water and decocting by boiling/simmering for 20 minutes (Pg. 40-41 ¶82-83); the resulting decoction is divided into 4 doses for administration (Pg. 41 ¶84). The administration method was gavage (Pg. 43 ¶88), i.e., force feeding – meaning the composition was formulated as an oral dosage form. SUN teaches the composition is effective in treating pneumonia with good efficacy (Pg. 42 ¶85). SUN also teaches the pneumonia targeted by the invention can be caused by pathogenic microorganisms such as viruses (Pg. 3 ¶4).
As evidenced by DOI, Polygonum cuspidatum is another name for Reynoutria japonica (Pg. 1 Other Scientific Names).
As evidenced by CHO, loquat is Eriobotrya japonica (Pg. 1 Right Col. ¶1).
As evidenced by MAMEDOV, the main active ingredient of licorice is glycyrrhizin (Pg. 1 ¶1).
ANSEL teaches the safe and effective dose of a drug depends on a number of factors including characteristics of the drug, the dosage form, and a variety of patient factors (Pg. 48 Left Col. para 2) and the effective dose may be different for different patients (Pg. 48 Left Col. para 4).
HUANG teaches remdesivir for treatment of SARS-CoV-2 associated pneumonia (Pg. 3 Left Col. ¶1), i.e., a viral-induced pneumonia.
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
SUN does not explicitly teach the instant concentrations (mg/mL) of each extract nor the composition further comprising remdesivir.
ANSEL does not teach the instant composition.
HUANG does not teach the instant composition of plant extracts nor their combination with remdesivir.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of a composition useful for treatment of viral-induced pneumonia and possesses the technical knowledge necessary to make adjustments to the composition to optimize/enhance the properties thereof. Said artisan has also reviewed the problems in the art regarding optimization of dosages and pneumonia anti-virals and understands the solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references SUN (as evidenced by DOI, CHO, & MAMEDOV), in view of ANSEL, and further in view of HUANG.
Regarding claims 11, 27-28, and 30, the artisan would be motivated to optimize the concentrations of the plant extracts in the pharmaceutical composition of SUN, especially in view of the teachings of ANSEL.
MPEP 2144.05(II)(A) provides guidance about the routine optimization of prior art conditions: "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.").”
Furthermore, MPEP 2144.05(I) provides guidance about overlapping ranges: “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists…Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.”
In the instant case, SUN teaches a composition comprising the extraction of 6-16 g of each of the claimed plants and grams of the other medicinal herbs (Pg. 15 ¶13 – Pg. 19 ¶25). Examiner calculated the composition comprising ~390 g of medicinal herbs, which corresponds to ~5400 mL of water (6x water + 8x water). This corresponds to at least 2-3 mg/mL of each of the instantly claimed plants in the unboiled mixture. The volume of the final decoction is not taught; however, based on the heats and times given in the method of making (Pg. 40-41 ¶82-83), the artisan would be able to replicate the final volumes. Since boiling will reduce the volume of the final decoction, SUN’s concentrations are considered to overlap with/approach the instantly claimed extracts of at least ~2.8 mg/mL of Andrographis paniculata, at least ~34.5 mg/mL of Eriobotrya japonica, and at least ~56 mg/mL of Reynoutria japonica. These limitations define the concentration of each extract in the claimed composition. Thus, they are analogous to the concentration recited in the MPEP and may be optimized by routine experimentation.
Further, since ANSEL teaches the safe and effective dose of a drug depends on a number of factors (Pg. 48 Left Col. para 2) and may be different for different patients (Pg. 48 Left Col. para 4), the artisan would recognize the concentration of each extract (i.e., equivalent to a dosage thereof) as a result-effective variable, i.e., a variable that achieves a recognized result. Thus, the concentrations thereof may be optimized by routine experimentation, as recited in the MPEP. Therefore, the determination of the optimum or workable concentrations of each extract would have been well within the practice of the artisan. Furthermore, absent any evidence demonstrating a patentable difference between the instant and prior art compositions and the criticality of the claimed dosage regimen, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the artisan.
Regarding claims 27-29, since SUN teaches the composition also comprises licorice (Pg. 6 ¶10), which comprises the active ingredient glycyrrhizin (MAMEDOV Pg. 1 ¶1), the artisan would recognize the composition as comprising the further therapeutic/antiviral agent of the instant claims. Since SUN teaches the composition as antiviral (Pg. 42 ¶85 & Pg. 3 ¶4), the artisan would recognize the components as antivirals.
Regarding claim 30, since SUN teaches administration by gavage (i.e., force feeding), the artisan would easily recognize the decoction/composition of SUN as formulated for oral administration.
Regarding claims 27-29 and the elected species remdesivir, the artisan would have been imbued with a reasonable expectation of success that by combining the composition of SUN with remdesivir, one would have achieved a composition useful for treating viral-induced pneumonia since both are taught by the prior art as suitable for the treatment of such disease (see: SUN Pg. 42 ¶85 & Pg. 3 ¶4; HUANG Pg. 3 Left Col. ¶1). As set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two agents each of which is taught by the prior art to be useful for the very same purpose. The idea of combining them flows logically from having been individually taught in the prior art.
Claims 11 and 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over:
ZHANG (CN 105833034, pub. 2016; cited in IDS of 03/28/2023; translation attached),
as evidenced by
LEE (Lee W. et al., J. Nat. Prod., 2010, 73, 854-859),
DOI (Department of Interior, Invasive Species Compendium: Japanese Knotweed Datasheet, 2010, retrieved from www.doi.gov/sites/doi.gov/files/migrated/invasivespecies/isac/2010/upload/ISC_Japanese_Knotweed_datasheet.pdf), and
CHO (Cho et al., Evidenced-Based Complementary and Alternative Medicine, 2016, 2016, 1-9; provided by Examiner 11/12/2025),
and in view of
ANSEL (Ansel, H.C. et al. Pharmaceutical Dosage Forms and Drug Delivery Systems, Lippincott Williams & Wilkins, 7th ed., 1999, pages 48-53).
Note, a machine translation of ZHANG is referenced below and is attached. Further, the following rejection is based upon art which was found incidental to the search for the elected species. This is not indicative that the entire scope of the claims has been examined; however, the following art is being applied in an effort to promote compact prosecution of the case.
Determining the Scope and Contents of the Prior Art:
ZHANG teaches a traditional Chinese medicine composition for treating asthma wherein the weights of the raw materials include: 20 g loquat leaf, 10 g Andrographis paniculata, 20 g Polygonum cuspidatum, and 10 g Salvia miltiorrhiza (Pg. 13-14 ¶20). ZHANG teaches to make the composition the herbal ingredients are added to water (enough to submerge by 8 cm) and boiled for 20-30 minutes to decoct (i.e., extract) and then more water is added (enough to submerge by 6 cm) for a second decoction lasting 15-20 minutes (Pg. 16 ¶25). The volume of the final decoction is taught as 400 mL and is taken as “juice” (Pg. 20 ¶34); i.e., the decoction is drunk by the subject and is an oral dosage form.
As evidenced by LEE, cryptotanshinone, dihydrotanshinone, tanshinone I, and tanshinone IIA are the active constituents of Salvia militorrhiza (Pg. 854 Abstract).
As evidenced by DOI, Polygonum cuspidatum is another name for Reynoutria japonica (Pg. 1 Other Scientific Names).
As evidenced by CHO, Loquat is Eriobotrya japonica (Pg. 1 Right Col. ¶1).
ANSEL teaches the safe and effective dose of a drug depends on a number of factors including characteristics of the drug, the dosage form, and a variety of patient factors (Pg. 48 Left Col. para 2) and the effective dose may be different for different patients (Pg. 48 Left Col. para 4).
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
ZHANG does not explicitly teach the instant concentrations (mg/mL) of each extract.
ANSEL does not teach the instant composition.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of a composition useful as a traditional Chinese medicine for asthma and possesses the technical knowledge necessary to make adjustments to the composition to optimize/enhance the effects thereof. Said artisan has also reviewed the problems in the art regarding dosing and concentrations of ingredients and understands the solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references ZHANG (as evidenced by LEE, DOI, & CHO) in view of ANSEL.
Regarding claim 11, the artisan would be motivated to optimize the concentrations of the plant extracts in the pharmaceutical composition of ZHANG, especially in view of the teachings of ANSEL.
See the rejection above (¶20) for the citations to MPEP 2144.05(I) & (II)(A) regarding the routine optimization of prior art conditions.
In the instant case, ZHANG teaches a composition comprising the extraction of 10 g or 20 g of each of the claimed plants and grams of the other medicinal herbs (Pg. 13-14 ¶20). The volume of the final decoction is taught as 400 mL (Pg. 20 ¶34). Assuming 100% extraction would get 25-50 mg/mL of each of the claimed plants; assuming 10% extraction would get 2.5-5.0 mg/mL of each of the claimed plants. From this and simple recreation of the decoction, the artisan would be able to calculate the mg/mL of each component of the decoction. ZHANG’s concentrations are considered to overlap/approach the instantly claimed extracts of at least ~2.8 mg/mL of Andrographis paniculata, at least ~34.5 mg/mL of Eriobotrya japonica, and at least ~56 mg/mL of Reynoutria japonica. These limitations define the concentration of each extract in the claimed composition. Thus, they are analogous to the concentration recited in the MPEP and may be optimized by routine experimentation.
Further, since ANSEL teaches the safe and effective dose of a drug depends on a number of factors (Pg. 48 Left Col. para 2) and may be different for different patients (Pg. 48 Left Col. para 4), the artisan would recognize the concentration of each extract (i.e., equivalent to a dosage thereof) as a result-effective variable, i.e., a variable that achieves a recognized result. Thus, the concentrations thereof may be optimized by routine experimentation, as recited in the MPEP. Therefore, the determination of the optimum or workable concentrations of each extract would have been well within the practice of the artisan. Furthermore, absent any evidence demonstrating a patentable difference between the instant and prior art compositions and the criticality of the claimed dosage regimen, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the artisan.
Regarding claims 27-29, since ZHANG teaches the composition also comprises Salvia miltiorrhiza (Pg. 13-14 ¶20) which has the active components cryptotanshinone, dihydrotanshinone, tanshinone I, and tanshinone IIA (LEE Pg. 854 Abstract), the artisan would understand the composition as also comprising the tanshinones recited in instant claim 29. While the instant claim recites these as antivirals and ZHANG is silent as to this property, such recitation is drawn to a property of the recited compounds, e.g., the tanshinones act as antivirals.
MPEP 2112.01.II states: "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Since ZHANG, as evidenced by LEE, teaches a compound of instant claim 29 (tanshinones), it would be expected that the compound would have the same properties as the compounds in the instant application, namely that the compound exhibits antiviral properties. i.e., is an antiviral agent.
Regarding claim 30, since ZHANG teaches the decoction is taken as a juice (Pg. 20 ¶34), the artisan would understand the decoction is drunk by the subject and is, therefore, formulated for oral administration.
Conclusion
Claims 11 and 27-30 are rejected.
Note: the search 6 (of the attached search notes) retrieved the reference AU 2020100566, published 05-28-2020 and effectively filed 04-15-2020. These dates are both before the instant EFD (09-28-2020); however, the document is not by another. Thus, the document does not qualify under 102(a)(2). Further, since this document is published during the 1-year grace period, and is not by any other inventors, the document is a clear exception from 102(a)(1) under 102(b)(1)(A). Thus, the document does not qualify as prior art.
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/S.E.B./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625