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 .
Claims 1-11 are pending and were examined on the merits.
Information Disclosure Statement
The information disclosure statement filed December 19th, 2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Specification
The disclosure is objected to because of the following informalities: the tables on pages 11-14, 16, and 18 are at least partially illegible, possibly because of poor scanning resolution. The applicant is advised to provide an electronic copy of the specification having legible tables.
The use of the terms "Waters", "Illumina", "HiSeq", and "Qiime", which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim Objections
Claims 1, are objected to because of the following informalities: the term "forsythia suspensa" should be italicized, and the first letter of the first word in the term capitalized, such that it reads "Forsythia suspensa", for proper binomial nomenclature. Appropriate correction is suggested.
Claims 9-11 are objected to because of the following informalities: the list " paste, syrup, tablet or capsule" should be written " paste, syrup, tablet, or capsule". Appropriate correction is suggested.
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 6-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the “use” claim attempt to claim a process without setting forth any steps involved in the process. "Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 ").
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 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a method to prepare a product of nature without significantly more, and a product of nature (Forsythia suspensa leaf extract). The claim(s) recite(s) a method of preparing a Forsythia suspensa leaf extract and a use of the extract to prepare a drug along with the Forsythia suspensa leaf extract. The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since claim 1 is directed to a method of preparing a Forsythia suspensa leaf extract, the claims are directed to a process. Since claim 5 is drawn to a product of Forsythia suspensa leaf extract, the claims are directed to a composition.
Effective January 7, 2019, subject matter eligibility determinations under 35 U.S.C. § 101 follow the procedure explained in the Federal Register notice titled 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No.4, 50-57), which is found at: https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf. Applicants are kindly asked to review this guidance as well as MPEP 2106.
The statutory categories of invention under 35 U.S.C. 101 are processes, machines, manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that these entities are not patentable subject matter. These judicial exceptions include abstract ideas, laws of nature, and natural phenomena. The Office released guidance on December 16, 2014 for the examination of claims reciting natural products under 35 U.S.C. 101 in light of the recent Supreme Court decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (569 U.S. ___, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013)) and Mayo Collaborative Services v. Prometheus Laboratories (566 U.S. ___, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012)), Diamond v. Chakrabarty, 447 U.S. 303 (1980)) and Funk Brothers Seed Co. v. Kalo Inoculant Co. - 333 U.S. 127 (1948)). (inter alia). See eg. MPEP 2106.04(b)
The Supreme Court has explained that the judicial exceptions reflect the Court’s view that abstract ideas, laws of nature, and natural phenomena are "the basic tools of scientific and technological work", and are thus excluded from patentability because "monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it." Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980 (quoting Myriad, 133 S. Ct. at 2116, 106 USPQ2d at 1978 and Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012)). The Supreme Court’s concern that drives this "exclusionary principle" is pre-emption. Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980. The Court has held that a claim may not preempt abstract ideas, laws of nature, or natural phenomena; i.e., one may not patent every "substantial practical application" of an abstract idea, law of nature, or natural phenomenon, even if the judicial exception is narrow.
While preemption is the concern underlying the judicial exceptions, it is not a standalone test for determining eligibility. Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir. 2016). Instead, questions of preemption are inherent in and resolved by the two-part framework from Alice Corp. and Mayo (the Alice/Mayo test referred to by the Office as Steps 2A and 2B). It is necessary to evaluate eligibility using the Alice/Mayo test, because while a preemptive claim may be ineligible, the absence of complete preemption does not demonstrate that a claim is eligible.
Products of Nature: When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". Products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad 133 S. Ct. at 2116-17, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature exception"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and "phenomena of nature"). Step 2A of the Office’s eligibility analysis uses the terms "law of nature" and "natural phenomenon" as inclusive of "products of nature".
PNG
media_image1.png
18
19
media_image1.png
Greyscale
It is important to keep in mind that product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. Instead, the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from its closest naturally occurring counterpart.
PNG
media_image1.png
18
19
media_image1.png
Greyscale
When a claim recites a nature-based product limitation, examiners 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. Nature-based products, as used herein, include both eligible and ineligible products and merely refer to the types of products subject to the markedly different characteristics analysis used to identify product of nature exceptions.
The Markedly Different Characteristics Analysis
The markedly different characteristics analysis is part of Step 2A, because the courts use this analysis to identify product of nature exceptions. If the claim includes a nature-based product that has markedly different characteristics, then the claim does not recite a product of nature exception and is eligible. If the claim includes a nature-based product that does not exhibit markedly different characteristics from its closest naturally occurring counterpart in its natural state, then the claim is directed to a "product of nature" exception (Step 2A: YES), and requires further analysis in Step 2B to determine whether any additional elements in the claim add significantly more to the exception.
PNG
media_image1.png
18
19
media_image1.png
Greyscale
Nature-based Product Claim Analysis
PNG
media_image1.png
18
19
media_image1.png
Greyscale
Where the claim is to a nature-based product by itself, the markedly different characteristics analysis should be applied to the entire product.
PNG
media_image1.png
18
19
media_image1.png
Greyscale
Where the claim is to a nature-based product produced by combining multiple components, the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts. Where the claim is to a nature-based product in combination with non-nature based elements, the markedly different characteristics analysis should be applied only to the nature-based product limitation. For a product-by-process claims, the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart.
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, and are evaluated based on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-based product limitation does not exhibit markedly different characteristics, then that limitation is a product of nature exception. If the analysis indicates that a nature-based product limitation does have markedly different characteristics, then that limitation is not a product of nature exception.
PNG
media_image1.png
18
19
media_image1.png
Greyscale
Because the markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state, the first step in the analysis is to select the appropriate counterpart(s) to the nature-based product.
PNG
media_image1.png
18
19
media_image1.png
Greyscale
When there are multiple counterparts to the nature-based product, the comparison should be made to the closest naturally occurring counterpart. When the nature-based product is a combination produced from multiple components, the closest counterpart may be the individual nature-based components of the combination. Because there is no counterpart mixture in nature, the closest counterparts to the claimed mixture are the individual components of the mixture, i.e., each naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281 (comparing claimed mixture of bacterial species to each species as it occurs in nature).
Markedly changed characteristics can include structural, functional, chemical changes. In order to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 133 S. Ct. at 2111, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, applicant must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart.
PNG
media_image1.png
18
19
media_image1.png
Greyscale
If there is no change in any characteristic, the claimed product lacks markedly different characteristics, and is a product of nature exception.
Step 1: Determine if the claims are directed to one of the four statutory categories of patentable subject matter identified by 35 U.S.C. 101: a process, machine, manufacture or composition of matter. YES, the claims are directed to a process and a composition of matter, which are statutory categories within at least one of the four categories of patent eligible subject matter.
Step 2A: PRONG ONE: Evaluate whether the claim recites a Judicial Exception
(e.g., law of nature, natural phenomenon, or an abstract idea; see MPEP 2106.04). YES, the claims are product claims reciting something that appears to be a nature-based product (i.e., Forsythia suspensa leaf extract) which is not markedly different from the closest naturally-occurring counterpart (i.e., the individual nature-based products).
Because the claim states the nature-based products which are plant extracts 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 Forsythia suspensa plants. This equates to a plant extract. The process of creating a plant extract is by partitioning the starting plant material into separate compositions based upon some property. The closest naturally occurring counterparts of extracted components are those same components when found existing in the plant in an unseparated form, even when purified and/or concentrated because they are chemically identical to the extracted compounds/components. 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 in the plant 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 plant extract composition is only comprising the nature-based components. 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)).
The claims as a whole do not amount to more than the recited exceptions because there aren’t any other additional elements to consider, which does not add an inventive concept to the claims. Thus, the claims are not eligible subject matter under current 35 U.S.C. 101 standards.
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.
Claims 3 and 6-11 are 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 3 recites the limitation "an ethanol elution" in the phrase "combining with an ethanol elution". There is insufficient antecedent basis for this limitation in the claim. The source of “an ethanol elution” is not explicitly stated beforehand.
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: what substance is being combined with an ethanol elution.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: the steps of preparing a drug are not disclosed. Claims dependent on claim 6 are rejected for failing to cure the indefiniteness.
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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Xuan and Huang (CN-1899382-B) in view of Wei (CN-112022904-A), Zhang and Tian (CN-106858555-A), and Taylor (Water-Immiscible Solvents as Sample Diluents in Reversed-Phase HPLC—You Must Be Joking!. LCGC The Column 2021, 17 (07)).
Claim 1 recites a method of making a Forsythia suspensa leaf extract as follows. Step 1: grinding forsythia leaves, then adding a solvent above a temperature of 90 °C for 10-40 minutes, filtering, then adding an extractant for more than 6 hours, resulting in a product. Step 2: the product that is filtered, providing a supernatant, adsorbing, and eluting. The eluate is concentrated under reduced pressure, providing a second product. Step 3: the second product is dissolved in water, and undergoes chromatography. Another eluate is then collected and concentrated under reduced pressure, providing an extract. Claim 2 recites that the solvent of Step 1 (in Claim 1) is water and the extractant is methanol, ethanol, or propanol. Claim 3 recites that in Step 2 (in Claim 2) elution is first done with water, then 30—60% ethanol, combining with an ethanol elution. Claim 4 recites that the second product (Claim 1) has a volume ratio of 1-10:5-50 to the water of Step 3 in Claim 1. Claim 5 recites a Forsythia suspensa leaf extract, prepared by the preparation method of claim 4 (dependent on claim 1).
Xuan and Huang recite a “method for preparing forsythia effective part” (claim 1), as follows:
“A, extracting with water: 8 times of deionized water, hot reflux extracting forsythia for 3 times, the extracting time is respectively 2, 2 and 1 hours, combining the water extract, filtering, 60 degrees centigrade decompressing and concentrating to the concentrated solution, to 50 degrees centigrade when relative density is 1.05-1.10, alcohol precipitation: putting A step water extracting concentrated solution adding ethanol until the ethanol concentration is 70-90 %, precipitated overnight, filtering it, combining the filtrates; decompressing and recycling the solvent until the concentrated liquid concentration is each ml g crude drug, filtering, macroporous resin absorption: step B obtained big hole absorption resin filter liquid is, firstly using 2. 5-8BV water eluting impurity, then using 1.0-3BV80 ethanol eluting, collecting ethanol eluent, decompressing and condensing, vacuum drying and crushing to obtain the forsythol effective part” (Xuan and Huang Claim 1).
Xuan and Huang recite a general process comprising the following steps. Extracting with hot water (applied to forsythia material), later adding ethanol to the water extract (compare with instant claim 1, step 1; instant claim 2). Filtering and absorption using macroporous resin (compare with adsorption in instant claim 1, step 2; the example use of macroporous resin recited in the instant specification paragraph [0039]). Elution using water followed by ethanol, and decompressing the eluate (instant claim 1, step 2; instant claim 3). The quantities recited in instant claim 1, step 1: “adding a solvent at a temperature above 90°C for 10 to 40 min, filtering and then adding an extractant for extraction for more than 6 hours” are understood as achievable through routine optimization for the following reasons. One of ordinary skill in the art would have been able to control such times and temperatures using equipment broadly known in the art (a hot plate with adjustable heat, a thermometer, and a timer). One of ordinary skill in the art would be able to study the effects of varying these times and temperatures on the therapeutic efficacy of the resulting extracts, through a genomic study of the intestinal flora of subject animals receiving the extracts (instant specification, Example 3). The use of 30-60% ethanol as recited in instant claim 3, if not already obvious over Xuan and Huang, would have been obvious over the course of routine optimization. Such routine optimization would have been achievable to one of ordinary skill in the art through the use of volumetric tools (such as micropipettes or volumetric flasks) to adjust percent volumes of water and ethanol in the elution solvent and a genomic study of the intestinal flora of subject animals receiving the resulting extracts (instant specification, Example 3).
Although not explicitly stated by Xuan and Huang, Zhang and Tian recite crushing dry Forsythia suspensa leaf before adding a solvent in an extraction procedure (Zhang claim 1). Crushing increases the surface area-to-volume ratio of plant material, making its chemical components more accessible to extraction solvents. Crushing is broadly understood as a similar action to grinding, both involving compressing and breaking a material. Therefore, preparing an extract of Forsythia suspensa leaves (instant claim 1) and grinding Forsythia suspensa leaves before adding a solvent (instant claim 1, step 1) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Dissolving the second product with as little organic solvent as possible before reverse phase chromatography is recited by Taylor:
“The chromatogram in Figure 2 highlights the issues with peak broadening and splitting due to the ‘differential’ sample elution speed of analytes in either the faster or slower eluting solvents. These peak shapes are far from ideal and will certainly give us problems with peak integration—and destroy the faith any reviewer of the data has in our abilities as chromatographers! There are several precautions that we can take to reduce these effects, including: Using the lowest amount of organic solvent within the diluent that will produce the required solubility characteristics for the analytes of interest; …” (Taylor, paragraphs 8-10).
Considering the peak integration problems from peak broadening and splitting, one of skill in the art would have been motivated to avoid these problems by using as little organic solvent as possible in the diluent of the second product before reverse-phase chromatography. Reverse phase chromatography is reasonably applicable as the form used in instant claim 1, step 3 (instant specification, paragraph [0040]). Therefore, one of skill in the art would have been motivated to dissolve the second product in water before chromatographic separation (instant claim 1, step 3). The acceptable volume ratios of the second product to water (instant claim 4) are routinely optimizable by those of ordinary skill in the art by ensuring that solutes from the second product do not loose solubility (observable through precipitation), and that broadening and splitting of chromatogram peaks is avoided as much as possible. Mixtures with volume ratios recited in instant claim 4 are achievable using volumetric measuring tools understood by those of ordinary skill in the art, for example micropipettes or volumetric flasks.
Chromatographic separation is broadly understood in chemical arts as a technique useful for separating dissolved chemical species in a mixture and its use in the preparation of a forsythia extract is recited by Wei (Wei, claim 15). It is within the ability for one of ordinary skill in the art to collect the eluates corresponding to different chromatographic peaks (signals) for further study. It is also within the ability for one of ordinary skill in the art to optimize extract preparation by testing the second product (instant claim 1, step 2) along with different chromatographic eluates for therapeutic effects on animal intestinal flora (instant specification, Example 3). Therefore, if not over Wei, then over routine optimization, performing chromatography, recited in instant claim 1 step 3, would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
A concentration step following the final elution is recited by Xuan and Huang in claim 1 supra, and would have increased the bioactive potency of the composition per unit volume. Therefore, this concentration step was obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Instant Claim 5 merely recites the extract prepared by the method of instant claim 4, dependent on instant claim 1; and both instant claims 1 and 4 are already argued supra as obvious over either prior art or routine optimization.
Considering the claims and references provided supra, the limitations of instant claims 1-5 would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Xuan and Huang (CN-1899382-B) in view of Wei (CN-112022904-A), Zhang and Tian (CN-106858555-A), and Taylor (Water-Immiscible Solvents as Sample Diluents in Reversed-Phase HPLC—You Must Be Joking!. LCGC The Column 2021, 17 (07)) as applied to claims 1-5 above, and further in view of Nishiyama et al. (Nutrients 2020, 12 (3), 839).
The claims and teachings of the cited references are as record above.
Claim 6 recites “A use of the forsythia suspensa leaf extract of claim 5 for preparing a drug that promotes the abundance of the bacteria species Akkermansia muciniphila or the bacteria genus Akkermansia in the intestinal tract of animals”. Claim 7 recites that the drug of claim 6 is an oral drug. Claim 8 recites that the animals recited in claim 6 are mammals. Claims 9, 10, and 11 (dependent on claims 6, 7, and 8, respectively) recite the dosage form of the drug as a paste, syrup, tablet, or capsule.
Nishiyama et al. describe the effects of dietary supplementation of Bofutushan (BTS) on the intestinal flora of mice (subheadings 2.2-2.6; instant claim 8), where dietary supplementation is broadly understood as occurring through oral administration (instant claim 7). Bofutushan is obtained by spray drying a hot water extract mixture, of which the fruit of Forsythia (“Forsythiae fructus”) is one component (subheading 2.1), as well as materials from other plant genera. Nishiyama et al. compared the BTS group of animals to a control (CONT) group without BTS administration (subheading 1). Genomic analysis demonstrated changes in intestinal flora upon BTS administration (subheading 3.2). Nishiyama et al. recite: “Noteworthy, the relative abundance of the genus Akkermansia at Week 1 was 3.17% in the BTS group, but below the detection limit (0.001%) for the CONT group (Table S3)” (second paragraph under subheading 3.2; compare instant claim 6). They also recite: “Noteworthy, the population of Akkermansia muciniphila, which is reported to elicit an anti-obesity effect and improve various metabolic abnormalities, was markedly increased (93-fold) compared with the CONT group” (Abstract; instant claim 6). It would have at least been obvious to one of ordinary skill in the art to try extracts of plant materials from different source genera of BTS, to understand which is/are necessary to induce the increase in intestinal Akkermansia muciniphila population. Therefore, the use of Forsythia suspensa leaf extract to promote the abundance of the bacteria species Akkermansia muciniphila in animals (instant claim 6) would have been obvious to try for one of ordinary skill in the art before the effective filing date of the claimed invention. Considering the experimental animals (mice) and dietary administration recited by Nishiyama et al., oral administration (instant claim 7), and changes in the intestinal flora of mammals (instant claim 8), would have also been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
The oral administration of a drug has been argued supra as obvious for Forsythia suspensa extract over Nishiyama et al. Oral administration of drugs are broadly understood in the art to be achievable through tablets and capsules (instant claims 9-11). Therefore, these dosage forms would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ methods with the methods (including compositions thereof) of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed methods and the methods of the prior art (and compositions thereof). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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, Terry McKelvey can be reached at (571) 272-0775. 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.
/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655