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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The priority date is January 20th, 2022.
Information Disclosure Statement
The information disclosure statement (IDS) filed July 22nd, 2024 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered. Non-patent literature document 1, on the IDS received July 22nd, 2024, is not in the English language, and has no concise explanation of relevance.
The information disclosure statement (IDS) submitted on September 10th, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on July 22nd, 2024. These drawings are acceptable.
Specification
The use of the terms Tween (including plural form “Tweens”), Witepsol, Lanette, Span, Cebes, hydrocote, hydrokote , Massa, Paramaount, T&P, Asan, and BioAssay Systems, each of which is a trade name or a mark used in commerce, has been noted in this application. Each term should be accompanied by the generic terminology; furthermore, each 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.
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 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. It is not clear what is meant by the phrase “naturally or artificially secreted” (claim 17), specifically how artificial secretion materially differs from natural secretion. This rejection could be overcome by amending claim 17 by removing the phrase “naturally or artificially”.
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 15-22 are rejected under 35 U.S.C. 103 as being unpatentable over Goodman et al. (US 20200254028 A1), abbreviated “Goodman”; and further in view of Kovarik (US 20190117709 A1), Kwon et al. (KR 20180065570 A) abbreviated “Kwon”, and Herranz et al. (US 20140369965 A1), abbreviated “Herranz”.
Claim 15 recites: ” A method of treating non-alcoholic fatty liver disease (NAFLD) comprising: administering to a subject in need thereof an effective amount of a composition comprising extracellular vesicles (EVs) derived from a Roseburia spp. strain, EVs derived from a Bifidobacterium spp. strain, or a combination thereof as active ingredients”. Claim 16 recites: “The method of claim 15, wherein the EVs have an average diameter of 30 nm to 200 nm”. Claim 17 recites: “The method of claim 15, wherein the EVs derived from a Roseburia spp. strain are naturally or artificially secreted from a Roseburia spp. strain; and the EVs derived from a Bifidobacterium spp. strain are naturally or artificially secreted from a Bifidobacterium spp. Strain”. Claim 18 recites: “The method of claim 15, wherein the Roseburia spp. strain is one or more selected from the group consisting of Roseburia intestinalis, Roseburia faecis, Roseburia hominis, and Roseburia inulinivorans”. Claim 19 recites: “The method of claim 15, wherein the Bifidobacterium spp. strain is one or more selected from the group consisting of Bifidobacterium longum, Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium lactis, and Bifidobacterium adolescentis”. Claim 20 recites: “The method of claim 15, wherein the NAFLD is one or more selected from the group consisting of steatosis, fibrosis, non-alcoholic steatohepatitis, non-alcoholic fatty liver (NAFL), and cirrhosis”. Claim 21 recites: “The method of claim 15, wherein the composition has one or more effect selected from the group consisting of: i) reducing serum aspartate aminotransferase (AST) levels or activity; ii) reducing serum alanine aminotransferase (ALT) levels or activity; iii) reducing serum total bilirubin (T-BIL) levels; Appl. No.: Not Yet Assigned Page 4 of 6 iv) reducing hepatic steatosis; v) reducing inflammatory cell infiltration; vi) reducing the number of inflammatory foci; and vii) reducing the number of myofibroblasts”. Claim 22 recites: ”The method of claim 15, wherein the composition is a pharmaceutical composition, a health functional food, or a feed composition”.
Goodman summarizes their invention in which bacterial extracellular vesicles are useful for treating certain diseases: “ In certain aspects, provided herein are pharmaceutical compositions comprising bacterial extracellular vesicles (EVs) useful for the treatment and/or prevention of disease (e.g., cancer, autoimmune disease, inflammatory disease, metabolic disease), as well as methods of making and/or identifying such EVs, and methods of using such pharmaceutical compositions (e.g., for the treatment of cancers, autoimmune diseases, inflammatory diseases, metabolic diseases, either alone or in combination with other therapeutics)” (paragraph [0002]; instant claims 15 and 22). It is also within the knowledge of one of skill in the art that bacterial extracellular vesicles, as recited above, are secreted by bacteria, and that such secretions would necessarily be either natural or artificial (instant claim 17).
Goodman clarifies the bacterial sources of extracellular vesicles (EVs) for their invention: “Examples of species and/or strains of bacteria that can be used to produce the EVs described herein are provided in Tables 1 and/or Table 2 and elsewhere throughout the specification” (paragraph [0080]).
Goodman recites the following Bifidobacterium species in Table 1: Bifidobacterium adolescentis, Bifidobacterium angulatum, Bifidobacterium animalis, Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium catenulatum, Bifidobacterium dentium, Bifidobacterium gallicum, Bifidobacterium infantis, Bifidobacterium kashiwanohense, Bifidobacterium longum, Bifidobacterium pseudocatenulatum, Bifidobacterium pseudolongum, Bifidobacterium scardovii, Bifidobacterium thermophilum, and Bifidobacterium urinalis (page 11, Table 1-continued, right column; instant claims 15, 17, and 19).
Goodman recites the following Roseburia species in Table 1: Roseburia cecicola, Roseburia faecalis, Roseburia faecis, Roseburia hominis, Roseburia intestinalis, and Roseburia inulinivorans (page 20, Table 1-continued, right column; instant claims 15, 17, and 18).
Goodman recites the diameter of extracellular vesicles, and the use of nanoparticle tracking analysis (NTA) and dynamic light scattering (DLS) to analyze a sample for particles within specific diameter ranges: “EVs are 20-250 nm in diameter. NTA will allow us to count the numbers of particles that are 50-250 nm in diameter. DLS reveals the distribution of particles of different diameters within an approximate range of 1 nm - 3 [μ]m” (paragraph [0100]; instant claim 16).
Goodman recites embodiments of their invention for treating non-alcoholic liver diseases: “In some embodiments, the methods and compositions described herein relate to the treatment of Nonalcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH)” (paragraph [0215]; instant claims 15 and 20). Goodman further recites: “In some embodiments, the methods and compositions described herein relate to the treatment of liver diseases. Such diseases include, but are not limited to, … , Cirrhosis, … , Non-Alcoholic Fatty Liver Disease, …” (paragraph [0216]; instant claims 15 and 20).
Goodman further recites health food and animal feed embodiments of their invention: “In some embodiments, the composition is a food product (e.g., a food or beverage) such as a health food or beverage, a food or beverage for infants, a food or beverage for pregnant women, athletes, senior citizens or other specified group, a functional food, a beverage, a food or beverage for specified health use, a dietary supplement, a food or beverage for patients, or an animal feed” (paragraph [0136]; instant claim 22).
Although Goodman does not explicitly recite an embodiment of their invention as a method of treating non-alcoholic fatty liver disease by administering EVs from Roseburia or Bifidobacterium, one of skill in the art would have had a reasonable expectation of success at concentrating the EVs using techniques recited by Goodman (paragraphs [0085] – [0089]; instant claim 15). One of skill in the art could administer concentrated EVs in pharmaceutical form or food form to a subject as recited previously by Goodman. The suggestion to use extracellular vesicles from Roseburia or Bifidobacterium is detailed below.
One of skill in the art had suggestion to use extracellular vesicles from Roseburia from Kovarik, who recites a method for reducing the likelihood of developing non-alcoholic steatohepatitis (NASH) in an individual diagnosed with non-alcoholic fatty liver disease comprising increasing the levels of Roseburia (Kovarik, claims 1, 5, 6, and 7; instant claims 15 and 18). Kovarik also recites “Levels of Roseburia are preferably increased” in the Field of the Invention (paragraph [0008]). Kovarik specifies increasing levels of Roseburia in a person’s gut microbiome (paragraph [0039]). Reducing the likelihood of NASH in an individual diagnosed with non-alcoholic fatty liver disease is reasonably encompassed in treating non-alcoholic fatty liver disease, as NASH is an inflammatory form of the disease in contrast to benign lipid accumulation in the liver: “Non-alcoholic fatty liver disease is a condition ranging from benign lipid accumulation in the liver (steatosis) to steatosis combined with inflammation. The latter is referred to as non-alcoholic steatohepatitis (NASH)” (Kovarik, paragraph [0014]). Kovarik further recites specific treatments encompassed by their invention “The present invention is directed in various embodiments directed to ways to modify the microbiota to treat hepatic steatosis, liver inflammation, fibrosis, and developing and advanced liver disease” (paragraph [0033]; instant claims 15, 18, and 21). Considering the subject matter recited by Kovarik, one of skill in the art would have had suggestion to use extracellular vesicles from Roseburia to treat non-alcoholic fatty liver disease instant claims 15 and 18). One of skill in the art also had suggestion that this treatment of non-alcoholic fatty liver disease encompasses treating hepatic steatosis and liver inflammation (Kovarik, paragraphs [0008] and [0033]; instant claim 21).
One of skill in the art had suggestion to use extracellular vesicles from Bifidobacterium from Kwon, who recites “A composition for preventing or treating (symptom alleviation) of fatty liver of the present invention contains any one selected from the group consisting of Bifidobacterium bifidum BGN4, Bifidobacterium longum BORI (AR81), L. acidophilus AD031, and combinations thereof as an active ingredient. (Kwon, Abstract; instant claims 15 and 19). Kwon explicitly recites pharmaceutical and food forms of their invention: “The present invention relates to a pharmaceutical composition or food composition for preventing or ameliorating fatty liver disease including bifidobacteria” (Kwon, Technical Field; instant claims 15, 19, and 22). Therefore, one of skill in the art would have had suggestion to administer extracellular vesicles from Bifidobacterium in a method of treating non-alcoholic fatty liver disease (instant claims 15 and 19).
Although neither Kovarik nor Kwon explicitly recite extracellular vesicles from Roseburia (Kovarik) or Bifidobacterium (Kwon), it is within the knowledge of one of skill in the art that extracellular vesicles carry material from the cells from which they originate. Therefore, the suggestions recited by Kovarik and Kwon reasonably apply not only to the cells of Roseburia and Bifidobacteria, respectively, but also the extracellular vesicles of these organisms (instant claims 15, 18, and 19). Furthermore, Herranz recites an invention that reasonably encompasses extracellular vesicles secreted from a Bifidobacterium strain for the treatment of fatty liver disease or hepatic steatosis: “The present invention relates to the Bifidobacterium CECT 7765 strain, to its cell components, metabolites, and secreted molecules, to the combinations thereof with other microorganisms, and to compositions comprising the aforementioned products, as well as to the use of a strain of the Bifidobacterium pseudocatenulatum species, or to using the CECT 7765 strain for the prevention and/or treatment of obesity, overweight, hyperglycemia and diabetes, preferably type 2 diabetes mellitus, hepatic steatosis or fatty liver, …” (Abstract, emphasis by the examiner; instant claims 15, 17, 20, and 21). Herranz clarifies in the Field of the Invention that CECT 7765 is a strain of Bifidobacterium pseudocatenulatum (paragraph [0002]), which is one of the species recited by Goodman, as of record above.
Although Herranz does not explicitly recite a Bifidobacterium species recited in instant claim 19, administering EVs from the species of instant claim 19 comprise a finite number of potential solutions to treat NAFLD with a reasonable expectation of success from the teachings of Kwon and Herranz, in view of their close phylogenetic relationship to Bifidobacterium pseudocatenulatum. Therefore, it is still obvious to one of skill in the art to try administering EVs from any of the Bifidobacterium species recited in instant claim 19 to treat non-alcoholic fatty liver disease.
From the teachings of Goodman, in further view of Kovarik, Kwon, and Herranz, and the knowledge of one of skill in the art, it would have been obvious to one of skill in the art to treat non-alcoholic fatty liver disease, by administering a composition comprising extracellular vesicles secreted from a Bifidobacterium and/or Roseburia species according to the limitations recited in instant claims 15-22.
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.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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