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 November 5, 2025 is acknowledged. Claim 1 is canceled. Claims 2-7 are amended and pending.
The previous 112(a) rejection and provisional non-statutory double patenting rejection in the Non-Final office action mailed August 5, 2025 are withdrawn due to Applicant’s amendment to the claims and submission of terminal disclaimer filed November 5, 2025.
Claim Objections
Applicant is advised that should claims 2 and 5 be found allowable, claims 3-4 and 6-7 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, i.e. additional intended use limitations, for treating nonalcoholic steatohepatitis, and for treating metabolic disease, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 2-7 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 2-7 recite Faecalibacterium prausnitzii EB-FPDK9 accession number: KCCM12620P and a pharmaceutical and food composition of the strain that is used for treating or ameliorating inflammatory disease, liver disease, and/or metabolic disease, which is a statutory category of invention (Step 1: Yes).
Claims 2-7 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 that would enhance functionality of treating inflammatory disease, metabolic disease, and liver disease, thus the claimed compositions are a judicial exception in the form of being a product of nature (Step 2A, Prong 1: Yes).
Claims 2-7 are drawn to the F. prausnitzii EB-FPDK9 accession number: KCCM12620P in a pharmaceutical 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 treat inflammatory disease, metabolic disease, and liver disease with 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 2-7 are not patent eligible subject matter. Applicant may obviate this rejection by deleting the powder and granule limitations in the instant claims.
Response to Arguments
Applicant's arguments filed November 5, 2025 have been fully considered but they are not persuasive.
Regarding remarks directed to the 101 rejection, Applicant argues the pharmaceutical composition in the form of a powder, granule, tablet, capsule, emulsion, syrup , or aerosol, containing the claimed strain or culture, is not found in nature. Similarly, the food composition in the form of a pill, powder, granule, tablet, or capsule, containing the claimed strain or culture, is not found in nature. Applicant argues the Examiner's position is improper for the analysis under 35 USC § 101. Notably, the Examiner has withdrawn the 102/103 rejection over Kawahara. The composition of the present invention is different from those in Kawahara. Substantial evidence was presented in the prior response that the instantly claimed composition containing the particular F. prausnitzii strain has markedly different characteristics from other F. prausnitzii strains. The present invention demonstrates a significantly enhanced effect over the Kawahara in the treatment of non-alcoholic steatohepatitis. Applicant argues the claimed invention demonstrates a comparable or superior therapeutic effect under significantly more challenging conditions, with respect to metabolic disease, thereby supporting that its effect is both remarkable and non-obvious over Kawahara, wherein the anti-inflammatory effects of the claimed invention are considered to be unexpected and non-obvious in view of Kawahara, and thus are patent eligible.
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 2-7 are not patent eligible.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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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.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/JESSICA EDWARDS/
Examiner, Art Unit 1657