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 have been cancelled. Claims 12-27 are new and are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/5/24 has been considered and an initialed copy is enclosed.
Claim Objections
Claim 12 is objected to because of the following informalities: Please insert “A” before “method” at the beginning of line 1. Appropriate correction is required.
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 12-27 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.
This rejection concerns the biological deposit for the F. prausnitzii strain deposited to the CNCM under the accession number I-4573.
The specification lacks complete deposit information for the deposit of this strain.
Because it is not clear that the bacteria is known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the claims requires the bacteria, a suitable deposit for patent purposes is required. Exact replication of the bacteria is an unpredictable event.
Applicant's referral to the deposit of the bacteria in the specification is an insufficient assurance that all required deposits have been made and all the conditions of 37 CFR §1.801-1.809 have been met.
If the deposit has been made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of deposit over his or her signature and registration number stating that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application and that the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of deposit and the complete name and full street address of the depository is required.
If the deposits have not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR §1.801-1.809, assurances regarding availability and permanency of deposits are required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring:
(a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request;
(b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application;
(c) the deposits will be maintained in a public depository for a period of at least thirty years from the date of deposit or for the enforceable life of the patent of or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and
(d) the deposits will be replaced if they should become nonviable or non-replicable.
In addition, a deposit of biological material that is capable of self-replication either directly or indirectly must be viable at the time of deposit and during the term of deposit. Viability may be tested by the depository. The test must conclude only that the deposited material is capable of reproduction. A viability statement for each deposit of a biological material not made under the Budapest Treaty must be filed in the application and must contain:
1) The name and address of the depository;
2) The name and address of the depositor;
3) The date of deposit;
4) The identity of the deposit and the accession number given by the depository;
5) The date of the viability test;
6) The procedures used to obtain a sample if the test is not done by the depository; and
7) A statement that the deposit is capable of reproduction.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
Applicant's attention is directed to In re Lundack, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR §1.801-1.809 for further information concerning deposit practice.
Claims 12-20, 26 and 27 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 cancer in a mammal patient, comprising administering to the patient an association of: a Faecalibacterium prausnitzii (F. prausnitzii) bacterial strain deposited to the CNCM under the accession number I-4573; and at least one immune checkpoint inhibitor; does not reasonably provide enablement for a method for preventing a cancer in a mammal patient, comprising administering to the patient an association of: a Faecalibacterium prausnitzii (F. prausnitzii) bacterial strain deposited to the CNCM under the accession number I-4573; and at least one immune checkpoint inhibitor.
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.
Enablement is considered in view of the Wands factors (MPEP 2164.01(A)). These include: nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art, predictability of the art and the amount of experimentation necessary. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the Invention
The claims are drawn in-part to: a method for preventing a cancer in a mammal patient, comprising administering to the patient an association of: a Faecalibacterium prausnitzii (F. prausnitzii) bacterial strain deposited to the CNCM under the accession number I-4573; and at least one immune checkpoint inhibitor.
Breadth of the Claims
The breadth of cancer includes but is not limited to fibrosarcoma, bladder cancer, breast cancer, cervix cancer, colorectal cancer, kidney cancer, lung cancer, lymphoma, leukemia, myeloma, melanoma, neuroblastoma, a Wilms tumor, oral or oropharyngeal cancer, pancreatic cancer, prostate cancer, retinoblastoma, thyroid cancer, uterine cancer, adenoid cystic carcinoma, adrenocortical tumor, chondrosarcoma, desmoid tumor, desmoplastic small round cell tumor, endocrine tumor, endodermal sinus tumor, epithelioid hemangioendothelioma, ewing sarcoma, nephroma, adrenal gland tumor, amyloidosis, anal cancer, appendix cancer, cholangiocarcinoma, glioma, non-rhabdomyosarcoma soft tissue sarcoma (NRSTS), paraspinal sarcoma, renal cell carcinoma, rhabdomyosarcoma, synovial sarcoma, bone cancer, brain cancer, central nervous system tumors, cervical cancer, esophageal cancer, eye cancer, eyelid cancer, gastrointestinal cancer, HIV/AIDS-related cancer, lacrimal gland cancer, laryngeal or hypopharyngeal cancer, leukemia, liver cancer, meningioma, nasopharyngeal cancer, ovarian cancer, fallopian tube cancer, peritoneal cancer, parathyroid cancer, penile cancer, salivary gland cancer, sarcoma, non-melanoma skin cancer, small bowel cancer, stomach cancer, testicular cancer, thymoma and thymic carcinoma, vaginal cancer and vulvar cancer.
Guidance in the Specification/The Existence of Working Examples
The specification teaches that alteration of the microbiota by antibiotics in tumor bearing mice compromises the anti-tumor effect of the immune checkpoint inhibitor anti-PD-L1. See example 1: effects of ABX on anti-PD-L1 mediated response. The specification discloses that the F. prausnitzii I-4573 is able to improve the anti-tumoral efficacy of the anti-PD-L1 treatment in the presence of antibiotics .
However, there is no working example in the specification on how to use an association of F. prausnitzii I-4573 and an immune checkpoint inhibitor to prevent a cancer in a mammalian patient.
State of the Art and Predictability of the Art
Cancer is a molecularly heterogeneous disease and there are in existence various types of tumors with different histopathologies, genetic and epigenetic variations and clinical outcomes. Ferreira et al (Ferreira, Daniela & Adega, Filomena & Chaves, Raquel. (2013). The Importance of Cancer Cell Lines as in vitro Models in Cancer Methylome Analysis and Anticancer Drugs Testing. 10.5772/1745).
Heterogeneity between and within these diseases seems to preclude any universal treatment against cancer (Corcos et al. Cancer Medicine 2013; 2(4):421-426).
The specification does not correlate the enhancement of the activity of an immune checkpoint inhibitor by virtue of association with the I-4573 strain with prevention of various types of cancer.
Immune checkpoint inhibitors are used for cancer immunotherapy and not generally known for prevention of cancer. See Saman et al. Discovery Oncology 2026 17:209, 56 pages.
For an unpredictable and a highly complex art which is the prevention of cancer more guidance and working example is needed. One of skill in the art as of the effective filing date would conclude that the treatment of cancer using the combination of the I-4573 strain and an immune checkpoint inhibitor would not be predictive of the efficacy of the combination for prevention of any type of cancer.
In view of the above considerations, the specification is not enabled for the full scope of the claims.
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 12-27 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.
The metes and bounds of “association” as used in the claims is vague. How is the F. prausnitzii associated with the immune check point inhibitor?
Regarding claim 21, the phrase “in particular” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 23 recites the limitation "wherein the mammalian patient" in line 1. There is insufficient antecedent basis for this limitation in the claim because claim 21 does not recite a mammalian patient.
Status of Claims
Claims 12-27 are rejected.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645