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 .
DETAILED ACTION
This application is a US national phase of PCT/KR2020/008345, with filing date June 26, 2020, and foreign priority application KR10-2020-0077337, filed 6/24/2020.
Applicant’s amendment filed April 22, 2026 is acknowledged. Claim 1 is canceled, and claims 8-9 are newly added. Claims 2-7 are amended. Currently claims 2-9 are pending and under examination.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 22, 2026 has been entered.
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.
(maintained) Claims 2 and 5 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
The Supreme Court has required analysis based on a 3-part test for subject
matter eligibility.
Step 1: Is the claim to a process, machine, manufacture, or composition of matter?
Step 2A (The Judicial Exceptions): Prong 1: Is the claim directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea?
Step 2A (The Judicial Exceptions): Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
Step 2B: Does the claim recite additional elements that amount to significantly
more than the judicial exception?
Claims 2 and 5 recite a Faecalibacterium prausnitzii EB-FPDK9 accession number: KCCM12620P and a pharmaceutical and food composition of the strain, which is a statutory category of invention (Step 1: Yes).
Claims 2 and 5 recite Faecalibacterium prausnitzii EB-FPDK9 accession number KCCM12620P that is a naturally occurring microorganism isolated from the feces of a healthy Korean woman (para 77). There is no evidence that the instant’s particular F. prausnitzii strain has any markedly different characteristic from other F. prausnitzii strains, nor that it has been genetically modified or altered, thus the claimed compositions are a judicial exception in the form of being a product of nature (Step 2A, Prong 1: Yes).
Claims 2 and 5 are drawn to the F. prausnitzii EB-FPDK9 accession number: KCCM12620P in a pharmaceutical composition or food composition in the form of a powder, granule, inter alia, however these forms are generic and well-understood in the industry, thus do not integrate the composition into a practical application, nor do they amount to significantly more than the judicial exception. As evidenced by Kawahara et al. (EP3639833A1, cited in IDS filed 10/29/2024), it well-understood and routine in the industry to formulate compositions comprising F. prausnitzii in the form of a pharmaceutical or food composition (abstract, claims 1, 2, 4, 5). Therefore, the F. prausnitzii EB-FPDK9 accession number: KCCM12620P strain is a naturally occurring organism, does not recite additional elements that integrate it into a practical application, nor recites additional elements that amount to significantly more than the judicial exception. (Step 2A, Prong 2: No) (Step 2B: No).
Therefore, claims 2 and 5 are not patent eligible subject matter. The terms “powder, granule,” can be deleted in claims 2 and 5 to obviate this rejection.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The breadth of the claims:
Claims 8-9 are drawn to a method for ameliorating or treating inflammatory disease comprising administering to a subject in need thereof a pharmaceutical or food composition comprising the FPDK9 strain. The breadth of the claims encompass any inflammatory disease, including the specification disclosed diseases: inflammatory skin20 disease inflammatory bowel diseases such as Crohn's disease and ulcerative colitis, hepatitis, peritonitis, osteomyelitis, cellulitis, meningitis, encephalitis, pancreatitis, cystic fibrosis, stroke, acute bronchitis, bronchitis, arthritis, articular cell arteritis, hemochromatosis, sicklemia and other hemoglobinopathies, and sepsis, and may preferably be inflammatory skin disease, colitis, chronic bronchitis, hepatitis, or osteoarthritis, but is not limited thereto [0051]. Thus, the claims are broad in that they include treatment and/or amelioration of a large number of conditions which would not be expected to be treated in the same manner with the same agents.
The nature of the invention:
The nature of the invention relies upon administering the FPDK9 strain to subject suffering from an inflammatory disease, wherein the effects of the strain decreases IL-8 levels and increases IL-10 levels to lipopolysaccharide (LPS) treated cells.
The state of the prior art:
Whether the specification would have been enabling as of the filing date involves consideration of the nature of the invention, the state of the prior art, and the level of skill in the art. The state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains. The relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed. See MPEP § 2164.05(b). The state of the prior art provides evidence for the degree of predictability in the art and is related to the amount of direction or guidance needed in the specification as filed to meet the enablement requirement. The state of the prior art is also related to the need for working examples in the specification.
A thorough review of the patent and non-patent literature indicates that the state of the art demonstrating FPDK9 strain as ameliorating or treating any inflammatory disease is lacking. As evidenced by Gerasimidis et al. (Inflamm Bowel Dis, 2014, Volume 20, Number 7, pgs. E18-E19), describes F. prausnitzii is unlikely to be the “keystone organism” of Crohn’s disease (CD) in all clinical situations, and a more complex role for F. prausnitzii than simply a “good guy” should at least be considered (pg. E19, col. 1, para 2). Gerasimidis et al. also discloses the large majority of intervention studies using prebiotics and/or probiotics to induce or maintain clinical remission in people with CD have produced disappointing results, and usage of butyrate enemas has been limited to patients with ulcerative colitis or in animal studies of colitis, which do not necessarily reflect disease pathogenesis in humans (pg. E19, col. 1, para 3).
Similarly, as evidenced by Eppinga et al. (Journal of Crohn's and Colitis, 2016, pgs. 1067–1075), found that a decrease in F. prausnitzii together with an increase in E. coli in the gut was associated with psoriasis, but no significant difference in these two bacteria were found in the inflammatory skin condition hidradenitis suppurativa, and might be thus specific for psoriasis and not apply to IBD-associated skin disorders in general (abstract, pg. 1073, col. 1, para 2).
Thus, a review of the prior art does not find a strong correlation between administering F. prausnitzii and treating and/or ameliorating the full scope of any type of inflammatory disease.
The level of one of ordinary skill and predictability in the art:
While the level of one of ordinary skill practicing said invention would be high, the level of predictability is considered variable as evident in the prior art discussed above and is not considered to provide sufficient enablement to practice the claimed invention. Because the state of the prior art does not provide evidence of the degree of predictability that methods for ameliorating and/or treating all inflammatory diseases by administering FPDK9, one of ordinary skill in the art would look for guidance or direction in the instant specification.
“The “predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability.” (MPEP 2164.03). In the instant case, the various conditions that fall within the scope of inflammatory diseases would require different treatment methods. For instance, inflammatory skin diseases or IBS would not necessarily be treated with the same agent or by the same mechanism.
The amount of direction provided by the inventor and existence of working examples:
The instant application describes the anti-inflammatory effect of FPDK9 on HT-29 intestinal epithelial cells and mouse bone marrow-derived dendritic cells, and found a significant increase in stimulating the anti-inflammatory cytokine IL-10 and significant decrease in the inflammatory cytokine IL-8, in cells exposed to LPS (Examples 2-3).
The working embodiments do not describe any other anti-inflammatory effect, nor do they describe how administering FPDK9 would effectively ameliorate and/or treat those conditions, only describing in-vitro effects on cells specifically stimulated with LPS. While the MPEP 2164.02 states the specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
The prior art is undeveloped for the role that FPDK9 plays in ameliorating and/or treating all types of inflammatory diseases, and given the broad scope of the claims and the different conditions encompassed, it is unpredictable if administering FPDK9 would reasonably ameliorate and/or treat all inflammatory diseases as claimed. The specification does not provide sufficient guidance on administering FPDK9 in the amelioration and/or treatment of the full scope of all inflammatory diseases. Rather the specification described examples related to lowering IL-8 and increasing IL-10 in pretreated cells. The prior art also does not provide additional guidance to enable treating the full scope of the claims.
Therefore, due to the unpredictability in the art with respect to ameliorating and/or preventing the full scope of the conditions which would be considered inflammatory diseases, one would have to engage in experimentation that is not reasonable in order to determine which of the various conditions could be treated by administering the F. prausnitzii FPDK9 strain.
Without further guidance, one of skill in the art would have to practice a substantial amount of trial-and-error experimentation, an amount considered undue and not routine, to practice the instantly claimed invention.
Claims 4 and 7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method for treating and/or ameliorating diabetes, hyperlipidemia, hypercholesterolemia, hyperglycemia, and obesity, by administering F. prausnitzii FPDK9 strain to a subject in need thereof, does not reasonably provide enablement for a method for treating and/or ameliorating all metabolic diseases. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The breadth of the claims:
Claims 4 and 7 are drawn to a method for ameliorating or treating metabolic disease comprising administering to a subject in need thereof a pharmaceutical or food composition comprising the FPDK9 strain. The breadth of the claims encompass any metabolic disease, including the specification disclosed diseases: hyperlipidemia, diabetes, gout, dementia, obesity, hypertension, hypoglycemia, hypercholesterolemia, hemochromatosis, amyloidosis, or porphyria, the diabetes may include type 1 diabetes and type 2 diabetes, preferably, the metabolic disease may be obesity, but is not limited thereto [0056]. Thus, the claims are broad in that they include treatment and/or amelioration of a large number of conditions which would not be expected to be treated in the same manner with the same agents.
The nature of the invention:
The nature of the invention relies upon administering the FPDK9 strain to subject suffering from a metabolic disease, wherein the effects of the strain reduces: weight gain, triglycerides, cholesterol, glucose, and improves non-alcoholic steatohepatitis pathology (related to lipid accumulation).
The state of the prior art:
Whether the specification would have been enabling as of the filing date involves consideration of the nature of the invention, the state of the prior art, and the level of skill in the art. The state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains. The relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed. See MPEP § 2164.05(b). The state of the prior art provides evidence for the degree of predictability in the art and is related to the amount of direction or guidance needed in the specification as filed to meet the enablement requirement. The state of the prior art is also related to the need for working examples in the specification.
A thorough review of the patent and non-patent literature indicates that the state of the art demonstrating FPDK9 strain as ameliorating or treating any type of metabolic disease is lacking. As evidenced by Danilowicz et al. (Diagnostics 2021, 11, 1279, pgs. 1-18), hereditary hemochromatosis is a genetic disease associated with iron overload disorder, caused by dysregulation of iron absorption and homeostasis, leading to excess deposition and oxidative injury, and is commonly treated with phlebotomy, chelating drugs, and erythrocytapheresis (pg. 13, para 2). Thus the evidence provided by Danilowicz teaches dysregulation of iron absorption and homeostasis, but the specification provides no data or guidance regarding iron metabolism, iron absorption, iron overload, or treatment disorders associated therewith.
Ueda et al. (Cell Reports Medicine 2021, 2, 100398, pgs. 1-22) showed evidence F. prausnitzii strains with specific orthologs are candidates for gut microbiome-based intervention in Alzheimer’s-type dementia (AD), and found 2 out of 12 F. prausnitzii strains isolated from healthy volunteers were effective in demonstrating part of the causal relationship between strains of F. prausnitzii and cognitive function in an AD mouse model, and found 6 orthologs other than OG0000713 and OG0000772 among 8 orthologs (Figure 6) that were not shared by the three known strains in the art (A2 165, S3L/3, and L2-6) (abstract, pg. 11, col. 2, para 3), underlining the difference among F. prausnitzii strains in effective treatment of AD.
Thus, a review of the prior art does not find a strong correlation between administering F. prausnitzii, specifically the FPDK9 strain, and treating and/or ameliorating the full scope of any type of metabolic disease.
The level of one of ordinary skill and predictability in the art:
While the level of one of ordinary skill practicing said invention would be high, the level of predictability is considered variable as evident in the prior art discussed above and is not considered to provide sufficient enablement to practice the claimed invention. Because the state of the prior art does not provide evidence of the degree of predictability that methods for ameliorating and/or treating all metabolic diseases by administering FPDK9, one of ordinary skill in the art would look for guidance or direction in the instant specification.
“The “predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability.” (MPEP 2164.03). In the instant case, the various conditions that fall within the scope of metabolic diseases would require different treatment methods. For instance, diabetes or dementia would not necessarily be treated with the same agent or by the same mechanism.
The amount of direction provided by the inventor and existence of working examples:
The instant application describes the effect of FPDK9 in a nonalcoholic steatohepatitis mouse model, and describes the strain reduced weight gain, improved cholesterol, triglycerides, glucose, and improved non-alcoholic steatohepatitis (NASH) pathology (related to lipid accumulation) (Examples 4-5).
The working embodiments do not describe any other metabolic deasease, nor do they describe how administering FPDK9 would effectively ameliorate and/or treat those conditions, only describing an in-vivo NASH mouse model evaluating specific characteristics and biomarkers of metabolic disease. While the MPEP 2164.02 states the specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
The prior art is undeveloped for the role that FPDK9 plays in ameliorating and/or treating all types of metabolic diseases, and given the broad scope of the claims and the different conditions encompassed, it is unpredictable if administering FPDK9 would reasonably ameliorate and/or treat all metabolic diseases as claimed. The specification does not provide sufficient guidance on administering FPDK9 in the amelioration and/or treatment of the full scope of all metabolic diseases. Rather the specification described examples related to improving certain metabolic characteristics and biomarkers in a NASH mouse model. The prior art also does not provide additional guidance to enable treating the full scope of the claims.
Therefore, due to the unpredictability in the art with respect to ameliorating and/or preventing the full scope of the conditions which would be considered metabolic diseases, except for Applicant’s demonstrated effects of FPDK9 strain on ameliorating and/or treating characteristics and biomarkers related to diabetes, hyperlipidemia, hypercholesterolemia, hyperglycemia, and obesity, one would have to engage in experimentation that is not reasonable in order to determine which of the various conditions could be treated by administering the F. prausnitzii FPDK9 strain.
Without further guidance, one of skill in the art would have to practice a substantial amount of trial-and-error experimentation, an amount considered undue and not routine, to practice the instantly claimed invention.
Allowable Subject Matter
Claims 3 and 6 are allowed. Claims 3 and 6 are drawn to a method for ameliorating or treating nonalcoholic steatohepatitis (NASH) by administering FPDK9 strain accession no. KCCM12620P to a subject in need thereof. There is no prior art teaching FPDK9 strain accession no. KCCM12620P. The closest prior art teaching of a probiotic effective in reversing NASH in a mouse model is taught by Jena et al. (HepatoBiliary Surg Nutr 2020;9(2):170-182); and F. prausnitzii as a target for growth in the gut as a treatment for increasing the bacterium in the gut in non-alcoholic fatty liver disease (NAFLD) as taught by Lensu et al. (Nutrients 2020, 12, 3225, pgs. 1-23).
Response to Arguments
Applicant's arguments filed April 22, 2026 have been fully considered but they are not persuasive. Regarding remarks directed to the 101 rejection, Applicant argues Applicant argues claims 2 and 5 recite compositions not found in nature and include additional components beyond the microbial strains, thus not directed to a product of nature. As discussed above in the 101 rejection, the markedly different characteristic analysis is determining if the compositional elements naturally occur in nature, and if those elements when combined confer markedly different characteristics than their natural counterparts occurring individually. As disclosed in the specification, the FBDK9 strain was isolated from human feces, and was not altered genetically in any way, nor is combined in the composition with any other element that would enhance functionality to its natural counterpart. Furthermore, generic pharmaceutical or food compositions that are in the form of a 'container' are not a part of the markedly different characteristic analysis, nor do they incorporate the composition into a practical application nor amount to significantly more than the judicial exception. The markedly different characteristic analysis is not based on different naturally occurring strains, whether that be differences between strains regarding genetics or therapeutic effects (See MPEP 2106.04(c)). Thus, the 101 rejection is maintained and claims 2 and 5 are not patent eligible.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA EDWARDS whose telephone number is (571)270-0938. The examiner can normally be reached M-F 8am-5pm EST.
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, Louise Humphrey can be reached at (571) 272-5543. 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.
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/JESSICA EDWARDS/
Examiner, Art Unit 1657
Prosecution Insights