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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/29/2026 has been entered.
Status of Claims
Following the Reply filed 01/29/2026, claims 1, 3 and 6-14 are pending in the application. Claims 1 and 6 have been amended without introducing new matter. Claims 1, 3 and 6-14 have been examined on the merits.
Withdrawn
The rejection of claims 1, 3 and 6-14 under 35 U.S.C. 103 in view of Wargo and Peters has been withdrawn upon further consideration by the examiner and in light of Applicant’s arguments. See Response to Arguments below for further discussion.
Claim Interpretation
Claims 1 and 6 have been amended to recite a composition comprising a Prevotella stercorea strain “as an active ingredient”. There being no special definition for this term in the instant specification, an “active ingredient” is broadly interpreted in accordance with its plain meaning, which is an ingredient that has a therapeutic effect.
As set forth in the Office Action filed 05/19/2025, the “subject in need thereof” recited in claim 1 is interpreted to include any subject. This interpretation is maintained as it applies to amended claim 1 and its dependents (i.e., claim 3).
As set forth in the previous Office Action, the limitation, “increases an anticancer effect”, recited in claim 3, includes increasing endogenous anticancer effects, as well as increasing the effects of exogenously administered agents. Accordingly, the claim does not require, nor does it exclude, the administration of other anticancer agents.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3 and 6-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Iezzi et al., WO 2019/149859 A1 (cited in the IDS filed 04/27/2023 at CITE NO. 15), hereafter, “Iezzi”.
Regarding claim 1, Iezzi teaches bacteria, selected from a panel of bacteria, for use in a method for the treatment or prevention of cancer (see pg. 3, lines 19-20), wherein the bacterium is administered to a patient in need (see pg. 12, line 2). Iezii teaches a particular embodiment where the bacterium is selected from Prevotella stercorea (see pg. 4, lines 3 & 18) or, in more particular embodiments, the bacterium is selected from the strains in Table 16 (see pg. 5, line 11) or in Table 3 (see pg. 8, line 12), which include Prevotella stercorea strain DSM 18206 (see pg. 17, Table 3; pg. 48, Table 16). Iezii teaches the method increases the number of beneficial tumor infiltrating lymphocytes present in a tumor (see pg. 1, lines 21-24). Hence, it is understood in view of Iezii’s disclosure that the method increases an immune response to cancer, which reasonably satisfies the limitation of a “method for enhancing immunity”. Iezii also teaches that the “bacterium” is provided in an “effective dose” (see, e.g., pg. 5, lines 12-14). Hence, the bacterium of Iezii is clearly provided “as an active ingredient”, because it is administered in an effective dose in order to achieve a therapeutic effect.
Regarding the limitation, “wherein the Prevotella stercorea strain is deposited under an accession number KCTC15079”, Iezii teaches the Prevotella stercorea strain, DSM 18206, as discussed above. As set forth under Claim Interpretation in the Office Action filed 05/19/2025, DSM 18206 is the same strain of Prevotella stercorea as KCTC 15079.
Therefore, Iezii teaches a method for treating cancer by enhancing immunity, the method comprising administering a composition comprising, as an active ingredient, a Prevotella stercorea strain to a subject in need, wherein the Prevotella strain is equivalent to the strain deposited under KCTC 15079.
Regarding claim 3, Iezii teaches the method increases the number of beneficial tumor infiltrating lymphocytes present in a tumor, as discussed above. Iezii specifically identifies the Prevotella stercorea strain, DSM 18206, as being among bacterial strains that were “associated with T cell recruitment in tumor tissues and [i]mproved prognosis” (see pg. 16, Table 3A). Hence, Iezii teaches the strain increases an anticancer effect.
Regarding claim 6, Iezii teaches a method for treating cancer by enhancing immunity, the method comprising administering a composition comprising a Prevotella stercorea strain to a subject in need thereof, wherein the Prevotella strain is equivalent to the strain deposited under KCTC 15079, as discussed above. Iezii further teaches a pharmaceutical composition comprising the bacteria that is administered concomitant (together) with an immune checkpoint inhibitory agent (see pg. 3, lines 15-17; pg. 12, lines 23-27).
Regarding claim 7, Iezii teaches the checkpoint inhibitory agent is selected from an inhibitor of the interaction of PD-1 or with its ligand PD-L1 (see pg. 13, lines 8-11).
Regarding claim 8, Iezii teaches the immune checkpoint inhibitor is atezolizumab (see pg. 10, lines 7-11).
Regarding claim 9, Iezii teaches the immune checkpoint inhibitor is nivolumab (see pg. 10, lines 7-11).
Regarding claim 10, Iezii teaches the pharmaceutical composition comprising the bacteria that is administered concomitant (together) with the immune checkpoint inhibitory agent, as discussed above, which meets the limitation of being “simultaneously administered”.
Regarding claim 11, in another embodiment, Iezii teaches the pharmaceutical composition comprising the bacteria is administered prior to administration of the checkpoint inhibitory agent (see pg. 12, lines 1-7), which meets the limitation of “sequentially administered”.
Regarding claim 12, Iezii specifically identifies the Prevotella stercorea strain, DSM 18206, as being among bacterial strains that were “associated with T cell recruitment in tumor tissues and [i]mproved prognosis” (see pg. 16, Table 3A). Iezii teaches that high densities of tumor infiltrating lymphocytes (TILs) including cytotoxic CD8+ T cells, are associated with prolonged patient survival (see pg. 1, lines 10-13). In Iezii’s Examples, the presence of gut microbiota enhanced CD4+ and CD8+ T cell recruitment into tumor xenografts (see pg. 30, lines 25).
Here, the phrase recited in the claim, “increases a proliferation of CD4+ T cells and CD8+ T cells” is reasonably interpreted to include increasing the number of CD4+ T cells and CD8+ T cells in tumor tissues, as disclosed by Iezii.
Nevertheless, the further limitation of the claim is directed to an inherent property of the bacterial strain itself, which is necessarily present in the Prevotella stercorea strain, DSM 18206. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). In the instant case, the prior art method recites administering the same bacterial strain to the same patient population, which, due to the inherent properties of the bacterium, is presumed to have the same effect. This is similar to Ex parte Novitski, 26 USPQ2d 1389 (Bd. Pat. App. & Inter. 1993):
The Board rejected a claim directed to a method for protecting a plant from plant pathogenic nematodes by inoculating the plant with a nematode inhibiting strain of P. cepacia. A U.S. patent to Dart disclosed inoculation using P. cepacia type Wisconsin 526 bacteria for protecting the plant from fungal disease. Dart was silent as to nematode inhibition but the Board concluded that nematode inhibition was an inherent property of the bacteria. The Board noted that applicant had stated in the specification that Wisconsin 526 possesses an 18% nematode inhibition rating.
Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). In this case, there is no further method step recited in the present claim, and the increase in “a proliferation of CD4+ T cells and CD8+ T cells” is presumed to be an inherent property of administering the bacteria. This determination of inherency is further supported by the relevant teachings of Iseii that are discussed above. See MPEP 2112.
Regarding claim 13, Iseii teaches the method “relates to the use of gut microbiota to elicit chemokine production within colorectal tumour tissues” (see pg. 1, lines 1-5). Iseii discloses that high densities of tumor infiltrating lymphocytes (TILs) including “IFN-g” expressing T-helper 1 cells (Th1) are associated with prolonged patient survival (see pg. 1, lines 10-13), and defined bacteria types were found to have the capacity to promote simultaneous recruitment of different T cell populations, consistent with the expression of Th1 observed in clinical samples, characterized by favorable prognosis (see pg. 34, lines 1-3). Hence, while Iseii does not explicitly teach the method “increases an interferon-γ (IFN-γ) secretion of T cells”, the reference reasonably suggests that the method increases expression of Th1 cells, which secrete cytokines that may include IFN-gamma.
Nevertheless, the claim does not recite a further active step but only a result that is expected to be achieved from the claimed method. Because the claim recites a result of the same method of administrating the same composition to treat cancer in the same patient population as Iseii, the claimed result is assumed to be an inherent property of administering the composition. This determination of inherency is further supported by the relevant teachings of Iseii that are discussed above. See also MPEP 2112 and the discussion regarding claim 12 above.
Regarding claim 14, Iseii teaches the bacterium is provided for preventing cancer, particularly colorectal cancer (see pg. 5, lines 18-19).
Response to Arguments
Applicant’s arguments, with respect to the anticipation rejection under 35 U.S.C. 102(a)(1) in view of Wargo, have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding the rejection under 35 U.S.C. 103, in view of Wargo and Peters, Applicant argues that the portions of Wargo disclosing embodiments involving the administration of bacteria do not include the Prevotella stercorea strain, and this strain is solely disclosed in methods for predicting therapeutic efficacy of immune checkpoint inhibitors (i.e., as a biomarker). See Remarks filed 01/29/2026 at page 6.
Applicant’s arguments have been fully considered and are persuasive.
Upon further consideration, the examiner notes that Wargo teaches two different methods involving two different sets of bacteria, and the portions which recite the Prevotella stercorea strain do not appear to be directed to the method of administering said bacteria. The examiner also notes that while Wargo does not appear to disclose the Prevotella stercorea strain in the method for administering, Wargo expressly teaches embodiments wherein the probiotic composition for administering “does not comprise bacterial species of the family Prevotellaceae” (see pg. 7, para. [0057]). As Wargo and Peters only teach and suggest Prevotella stercorea to be useful as a prognostic marker and do not teach its use as therapeutic agent, there is a reasonable doubt that a person of skill would have had sufficient motivation, in view of these two specific references, to have selected this strain from the numerous number of strains (reasonably, more than 1,000) recited in Wargo’s disclosure.
Accordingly, the rejection under 35 U.S.C. 103 has been withdrawn.
Conclusion
No claims are allowed.
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/DENNIS IGNATIUS ARMATO JR/Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651