DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Amendments and Remarks, filed 14 June 2024, in the matter of Application N° 18/720,104. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
No claims have been added, amended, or canceled.
No new matter has been added.
Thus, claims 1-12 represent all claims currently under consideration.
Information Disclosure Statement
Two Information Disclosure Statements (IDS) filed 14 June 2024 and 11 April 2025 are acknowledged and have been considered.
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 13-22 are rejected under 35 U.S.C. 112, first paragraph, as containing 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 invention appears to employ a specific strain of Akkermansia muciniphila EB-AMDK39. It is not clear if the written description is sufficiently repeatable to avoid the need for a deposit. Further it is unclear if the starting materials were readily available to the public at the time of invention.
It appears that a deposit was made in this application as filed as noted on page 53 of the specification. However, it is not clear if the deposit meets all of the criteria set forth in 37 CFR 1.801-1.809. Applicant or applicant's representative may provide assurance of compliance with the requirements of 35 U.S.C § 112, first paragraph, in the following manner.
SUGGESTION FOR DEPOSIT OF BIOLOGICAL MATERIAL
A declaration by applicant, assignee, or applicant's agent identifying a deposit of biological material and averring the following may be sufficient to overcome an objection and rejection based on a lack of availability of biological material.
1. Identifies declarant.
2. States that a deposit of the material has been made in a depository affording permanence of the deposit and ready accessibility thereto by the public if a patent is granted. The depository is to be identified by name and address.
3. States that the deposited material has been accorded a specific (recited) accession number.
4. States that all restriction on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
5. States that the material has been deposited under conditions that access to the material will be available during the pendency of the patent application to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C § 122.
6. States that the deposited material will be maintained with all the care necessary to keep it viable and uncontaminated for a period of at least five years after the most recent request for the furnishing of a sample of the deposited microorganism, and in any case, for a period of at least thirty (30) years after the date of deposit for the enforceable life of the patent, whichever period is longer.
7. That he/she declares further that all statements made therein of his/her own knowledge are true and that all statements made on information and belief are believed to be true, and further that these statements were made with knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the instant patent application or any patent issuing thereon.
Alternatively, it may be averred that deposited material has been accepted for deposit under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the purpose of Patent Procedure (e.g. see 961 OG 21, 1977) and that all restrictions on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
Additionally, the deposit must be referred to in the body of the specification and be identified by deposit (accession) number, date of deposit, name and address of the depository and the complete taxonomic description.
While page 53 of the Specification meets a few of the requirements listed above, such as depositing authority and accession number, it does not include a large portion of the information required for the depository.
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 8 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.
The limitations of claim 8 recite, in dependence directly from claim 1, wherein the composition further comprises an Akkermansia sp. .
The claim is considered indefinite since claim 1 already recites an Akkermansia sp. and it is unclear from either recitation exactly what is being added to the claimed invention with the limitations of claim 8.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. As discussed above, claim 1 already recites a composition with a compound related to Akkermansia sp.
Claim 8 recites that the composition of claim 1 further contains an Akkermansia sp., but does not say what is actually included. As such, claim 8 is not considered to further limit the composition recited by claim 1.
Applicants may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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 1-6 and 8-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of product of nature without significantly more.
Claims 1-6 and 8-12 are drawn to the statutory category of products (Step 1: Yes).
Claim 1 recites the generic bacterial strain Akkermansia sp. Claim 2 recites Akkermansia sp. is Akkermansia muciniphila. Claim 3 recites that the Akkermansia sp. is Akkermansia muciniphila EB-AMDK39 with deposit number KCTC 13765BP.
Akkermansia muciniphila EB-AMDK39 is a naturally-occurring, mucin-degrading bacterium commonly found in the human gut (see e.g., Abstract; Zhou; JFF; 2017).
Claim 4 simply recites a particle size range for the EVs derived from Akkermansia muciniphila EB-AMDK39.
Claim 5 recites types of cancer that further limit the intended use recited by claim 1.
Claim 6 recites that the composition of claim 1 will further comprise a cancer treatment selected from a chemotherapeutic agent and a cancer immunotherapeutic agent.
The limitations of claim 8 are discussed above.
Claim 9 recites whereby the Akkermansia sp. EVs are administered with or individually from the cancer chemotherapeutic or a cancer immunotherapeutic agents.
Claims 10 and 11 respectively recite a “health functional food” and a “veterinary composition” comprising the composition of claim 1. The preambles to these claims are not considered to provide any distinction over the composition of claim 1.
Lastly, claim 12 simply recites “[a]n Akkermansia muciniphila EB-AMDK39 strain (KCTC 13765BP).”
Claims 1-6 and 8-12 do not recite any additional non-natural compounds or structures of the compositions, thus the claims recite a judicial exception of a product of nature (Step 2A Prong One: Yes).
This judicial exception is not integrated into a practical application, nor do the claims include additional elements that are sufficient to amount to significantly more than the judicial exception, because the claims are drawn to the statutory category of products, and the claims do not recite any applications of the products. Although claims 1 and 10-12 recite that their product of nature compositions can be used to prevent or treat cancer or inflammatory disease, or used as health food or veterinary compositions, these limitations do not integrate the claimed compositions into a practical application because the claims do not require any active steps be performed such that the product of nature compositions are required to be used or applied in some way to achieve these anti-renal disease properties. Thus, the instant invention is directed to the judicial exception of a product of nature (Step 2A Prong Two and Step 2B: No).
Therefore, the instant invention is directed to a product of nature without significantly more and is not patent eligible subject matter under 35 USC §101.
Claim Rejections - 35 USC §102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Luo et al. (International J. Med.; 2021).
The limitations of the claimed invention are discussed above.
Luo discloses an effective dose of Akkermansia muciniphila-derived extracellular vesicles (aka Akk-EVs), administered intravenously to treat prostate cancer (see e.g., Abstract). The Akk-EVs are further defined as having cup-shaped or spherical morphologies with a diameter of 181.9 ± 42.4 nm or 139.5-224.3 nm (see pg. 2953; Results; first paragraph).
The foregoing meets the limitations of claims 1, 2, and 5.
The limitations of claim 3 and 4 are also considered to be met as the recited EVs are “derived from” Akkermansia muciniphila EB-AMDK39. As they are derived therefrom, the Examiner submits that it is not immediately clear how distinct the resulting EVs are from the originating strain. As such, the reference is considered to read on these claims.
Though directed to further limiting the intended cancer to be treated, the limitations of claim 5 are also met, not only by the teaching of the injected composition, but also that it is targeting prostate cancer (see e.g., Title).
The limitations of claims 6, 7, and 9 are considered to be disclosed (see pg. 2959; Discussion; right col.). Therein, it is disclosed that “[r]emarkably, Akk has also been reported to impact cancer immunotherapy. It was demonstrated that compared to those who showed no response to anti-PD-1-based immunotherapy, responding patients with non-small-cell lung cancer or renal cell carcinoma had relatively high levels of the bacterium Akk. Supplementation with Akk can restore the efficacy of PD-1 blockade efficiency.”
The reference is thus considered to teach each of the instantly claimed limitations.
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615