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 .
Election/Restrictions
Applicant’s election without traverse of Group I, new claims 22-29, in the reply filed on October 21, 2025 is acknowledged.
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.
1. Claims 26 and 29 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 specification lacks complete deposit information for the deposit of GDMCC NO 61121, it is not clear that cells possessing the identical properties of GDMCC NO 61121 are known and publicly available or can be reproducibly isolated from nature without undue experimentation.
Exact replication of a cell is an unpredictable event. Although applicant has provided a written description of a method for selecting the claimed cell, this method will not necessarily reproduce cells which are chemically and structurally identical to those claimed. Undue experimentation would be required to screen all of the possible species to obtain the claimed cells.
Because one skilled in the art could not be assured of the ability to practice the invention as claimed in the absence of the availability of the GDMCC NO 61121, a suitable deposit for patent purposes, evidence of public availability of the GDMCC NO 61121 cells or evidence of the reproducibility without undue experimentation is required.
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. 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.
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.
If the deposit was made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the cell line described in the specification as filed is the same as that deposited in the depository. Corroboration may take the form of a showing of a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant's possession at the time the application was filed.
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.
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.
2. Claim(s) 22-25 and 27-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Culler et al.
The claims are drawn to a composition comprising Enterococcus lactis and an additional drug selected from a chemotherapeutic agent, photosensitizer, photothermal agent, antibody of inhibitory second signaling molecule, inhibitor of inhibitory second signaling molecule, PD-L1 inhibitor, and PD-1/PD-L1 monoclonal antibody.
Culler et al (WO 2019/178542) disclose of compositions for the treatment of cancer comprising inhibitors of signaling molecules, CTLA-4 and PD-L1. (See claim 13). Culler et al further disclose of the composition comprising Enterococcus lactis. (See claim 20). Culler et al further disclose that the inhibitor of signaling molecules may comprise pembrolizumab. (See page 13).
Accordingly, Culler et al disclose of each and every limitation of the instantly filed claims.
Claim Rejections - 35 USC § 103
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.
3. Claim(s) 22-25 and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Nami et al in view of McNeel et al.
The claims are drawn to a composition comprising Enterococcus lactis and an additional drug selected from a chemotherapeutic agent, photosensitizer, photothermal agent, antibody of inhibitory second signaling molecule, inhibitor of inhibitory second signaling molecule, PD-L1 inhibitor, and PD-1/PD-L1 monoclonal antibody.
Nami et al (Frontiers in Microbiology Vol. 6, Article 1317, pp 1-11, 2015) teach Enterococcus lactis IW5 decreased the viability of different cancer cells. (See abstract).
Nami et al do not teach of additional drugs selected from a chemotherapeutic agent, photosensitizer, photothermal agent, antibody of inhibitory second signaling molecule, inhibitor of inhibitory second signaling molecule, PD-L1 inhibitor, and PD-1/PD-L1 monoclonal antibody.
McNeel et al (US Publication 2017/0182139) teach of compositions for treating cancer comprising PD-1 inhibitors. (See claim 1). McNeel et al further disclose the composition comprising pembrolizumab. (See claim 6).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have combined Enterococcus lactis as taught by Nami et al with pembrolizumab as taught by McNeel et al. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark NAVARRO whose telephone number is (571)272-0861.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached at 571 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALBERT M NAVARRO/Primary Examiner, Art Unit 1645 November 6, 2025