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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/20/2026 has been entered.
Status of Claims
Claims 1, 3 and 6-14 are pending following the Reply filed 08/20/2026. Claim 3 has been amended without introducing new matter. All pending claims have been examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) filed 08/24/2026 has been considered by the examiner.
Claim Interpretation
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 claim 1 and its dependents (i.e., claim 3).
As set forth in the Office Action filed 11/14/2025, 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.
Maintained Rejections
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). Iezzi teaches the bacterium for use in the method of treating cancer belongs to a strain listed in Table 3A (see pg. 11, lines 33-34)
which includes Prevotella stercorea strain DSM 18206 (see pg. 17, Table 3A). Iezzi also teaches that the “bacterium” is provided in an “effective dose” (see, e.g., pg. 5, lines 12-14) which meets the limitation of “an active ingredient”, because the bacterium is clearly administered to achieve a therapeutic effect.
Regarding the limitation, “wherein the Prevotella stercorea strain is deposited under an accession number KCTC15079”, Iezzi 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, Iezzi teaches a method for treating cancer, 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, which meets the claim.
Regarding the phrase “for enhancing immunity” recited in the preamble, Iezzi 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 Iezzi’s disclosure that the method increases an immune response to cancer, which reasonably satisfies a “method for enhancing immunity”.
However, the phrase “for enhancing immunity” recited in the preamble, is directed to an intended use which does not amount to any manipulative difference in the steps of the claimed process. As discussed under Claim Interpretation, the claim is directed to administering the composition to any subject. Per MPEP 2112.02, when the claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978). In the instant case, Iezzi teaches the same process of administering the same composition to the same patient population, and the claim is anticipated whether or not the effects recited in the claim were explicitly taught by the prior art reference.
Regarding claim 3, Iezzi teaches the method increases the number of beneficial tumor infiltrating lymphocytes present in a tumor, as discussed above. Iezzi 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). Therefore, Iezzi reasonably teaches this strain to increase an anticancer effect.
However, the functional limitation of “wherein the cancer increases an anticancer effect” does not amount to any manipulative difference in the steps of the claimed process and is directed to an inherent property of the composition comprising the Prevotella strain, which is the same strain taught by Iezzi. Per MPEP 2112.01, "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, Iezzi teaches the same process of administering the same composition to the same patient population, and the claim is anticipated whether or not the effects recited in the claim were explicitly taught by the prior art reference.
Regarding claim 6, Iezzi teaches a pharmaceutical composition for the treatment of cancer comprising one of the bacteria specified in Table 3A that is administered concomitant (together) with an immune checkpoint inhibitory agent (see pg. 12, lines 15-17, 23-27; note that “Item 10” depends from “Item 8”). As previously discussed, Table 3A includes Prevotella stercorea strain DSM 18206, which is equivalent to the claimed strain.
Regarding claim 7, Iezzi 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, Iezzi teaches the immune checkpoint inhibitor is atezolizumab (see pg. 10, lines 7-11).
Regarding claim 9, Iezzi teaches the immune checkpoint inhibitor is nivolumab (see pg. 10, lines 7-11).
Regarding claim 10, Iezzi 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, Iezzi teaches the pharmaceutical composition for the treatment of cancer, wherein said pharmaceutical composition comprises one bacteria selected from Table 3A, and is administered prior to administration of a checkpoint inhibitory agent (see pg. 13, lines 1-7), which meets the limitation of “sequentially administered”.
Regarding claim 12, Iezzi 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). Iezzi 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 Iezzi’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 Iezzi.
However, the functional limitation of “wherein the Prevotella stercorea strain… increases a proliferation of CD4+ T cells and CD8+ T cells” does not amount to any manipulative difference in the steps of the claimed process and is directed to an inherent property of the Prevotella strain, which is the same strain taught by Iezzi. 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.
Per MPEP 2112.01, "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). 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 the instant case, Iezzi teaches the same process of administering the same Prevotella strain to the same patient population, and the claim is anticipated whether or not the effects recited in the claim were explicitly taught by the prior art reference.
Regarding claim 13, Iezzi teaches the method “relates to the use of gut microbiota to elicit chemokine production within colorectal tumour tissues” (see pg. 1, lines 1-5). Iezzi 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 Iezzi 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.
However, the functional limitation of “wherein the Prevotella stercorea strain… increases an interferon-γ (IFN-γ) secretion of T cells” does not amount to any manipulative difference in the steps of the claimed process and is directed to an inherent property of the Prevotella strain, which is the same strain taught by Iezzi. See MPEP 2112 and the discussion regarding claim 12 above. In the instant case, Iezzi teaches the same process of administering the same Prevotella strain to the same patient population, and the claim is anticipated whether or not the effects recited in the claim were explicitly taught by the prior art reference.
Regarding claim 14, Iezzi teaches the cancer is colorectal cancer (see Abstract, pg. 8, line 23; pg. 12, lines 8-9).
Response to Declaration under 37 C.F.R. § 1.132
The declaration under 37 CFR 1.132 filed 08/20/2026 is insufficient to overcome the rejection of claims based upon 1, 3 and 6-14 as set forth in the last Office action because:
The facts presented are not germane to the rejection at issue.
The declaration sets forth the following observations and opinions by the inventor of the present application regarding the prior art of Iezzi:
A statistical correlation between the abundance of a bacterial taxon in tissue and the expression level of certain markers does not establish, and cannot by itself support a reasonable expectation that administration of that taxon to a subject would enhance immunity or treat cancer. Correlation observed in Table 3A of Iezzi is not evidence of a causal treatment effect. (see pg. 2, para. 5-2)
Iezzi’s own Example 7 undermines any inference of a beneficial effect from Table 3A, indicating a teaching away from Prevotella stercorea (see pg. 2, para. 5-3)
Candidate species identified solely through Iezzi’s correlation-based methodology, without direct experimental confirmation, may exhibit various effects, and no reasonable expectation of any particular beneficial effect can be drawn from Table 3A alone. (see pg. 4, para. 5-5)
Iezzi’s statement that “defined bacteria types were found to have the capacity to promote simultaneous recruitment of different T cell populations” relied upon by the Examiner in connection with Claim 13, is a generalized inference drawn from a Spearman correlation matrix and not a finding specific to Prevotella stercorea. A statistical correlation observed in patient tissue samples does not establish, and cannot by itself support a reasonable expectation that the Prevotella stercorea would have these effects. (see pg. 5, para. 5-7)
In contrast to Iezzi, the present specification provides direct experimental evidence that administration of the Prevotella stercorea strain alone did not produce a statistically significant reduction in tumor growth, whereas administration of the Prevotella stercorea strain in combination with a PD-1 inhibitor produced a statistically significant anticancer effect, which a person of ordinary skill would not have had a reasonable expectation of in view of Iezzi (see pgs. 5-6, para. 6). The inventor proceeds to provide experimental evidence to support the anticancer effect of the Prevotella stercorea + PD-1 inhibitor combination on pages 6-7 of the declaration.
The facts presented by the inventor, as outlined above, are not germane to the rejection at issue, because they substantially relate to rebutting a finding of obviousness (35 U.S.C. 103), whereas the claims are rejected as being anticipated under 35 U.S.C. 102. Per MPEP 2131.04, evidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. 102 rejections and thus cannot overcome a rejection so based. In re Wiggins, 488 F.2d 538, 543, 179 USPQ 421, 425 (CCPA 1973). Furthermore, the declaration’s allegation that there was no “reasonable expectation” of success when applying Iezzi’s teachings or that Iezzi allegedly “teaches away” from the claimed invention are factors that are only considered under 35 U.S.C. 103, and cannot be used to overcome a finding of anticipation under 35 U.S.C. 102. See below for further discussion.
The declaration further states:
Iezzi does not disclose that Prevotella stercorea, or any bacterium of Table 3A, was ever isolated and administered to a subject to test for an anticancer or immune-enhancing effect. (see pg. 2, para. 5-1)
Iezzi’s disclosure regarding combined administration with a checkpoint inhibitor is “internally inconsistent”, because Iezzi teaches embodiments both including and excluding Prevotella stercorea. In view of this “internal contradiction”, Iezzi cannot be said to disclose, clearly and without ambiguity, the combined administration as recited in claim 6. (see pg. 3, para. 5-4)
Iezzi’s disclosure regarding a general effect of “gut microbiota” on T cell recruitment (relied upon by the Examiner in connection with Claim 12) does not identify Prevotella stercorea as responsible for that effect. (see pgs. 4-5, para. 5-6)
First, the declaration appears to allege that the prior art reference was not operable and/or enabling based solely on a lack of “proof” that the teachings of Iezzi would have been effective. However, this is not a sufficient reason for one to conclude that a person of ordinary skill would not be able to carry out the claimed invention and fails to overcome the presumption that the Iezzi reference was operable and enabled.
Per MPEP 2121: When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). A prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; "proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation." Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006) (citing Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326, 75 USPQ2d 1297, 1302 (Fed. Cir. 2005)) (Emphasis added).
Here, the declaration incorrectly implies that “proof of efficacy” is required to maintain the rejection, while failing to specifically point out how the Iezzi reference was inoperable or unenabled (i.e., how administering a Prevotella stercorea strain to a subject in need would warrant undue experimentation). The examiner notes that Iezzi provides guidance regarding how to prepare and administer bacteria and other anti-cancer treatments (see, e.g., pg. 8, lines 16-22; pg. 11, lines 5-19), and these agents and how to use them appear to have been already known in the prior art. Therefore, the examiner maintains the presumption that a person of ordinary skill would have been able to carry out the method taught by Iezzi which anticipates the invention of the claims.
Second, the declaration’s statement regarding the “internal inconsistency” of Iezzi on page 3, para. 5-4 appears to be due to the fact that Iezzi teaches multiple embodiments. This is irrelevant to the rejection at issue, because a reference may be relied upon for any embodiment, including nonpreferred embodiments. Furthermore, under 35 U.S.C. 102, a rejection may even rely on embodiments to which the reference disparages or teaches away from.
Per MPEP 2123: “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). Further, “[a] reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). (Emphasis added)
Per MPEP 2131.05: A reference is no less anticipatory if, after disclosing the invention, the reference then disparages it. The question whether a reference "teaches away" from the invention is inapplicable to an anticipation analysis. Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The prior art was held to anticipate the claims even though it taught away from the claimed invention. "The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed."). (Emphasis added)
In the instant case, Iezzi teaches an embodiment where the Prevotella stercorea strain is administered with a checkpoint inhibitory agent. There is simply no requirement that all embodiments of a disclosure must rise and fall together, to have been demonstrated to have been effective or otherwise, in order for a particular embodiment to be relied upon in a rejection under 35 U.S.C. 102.
Finally, it should be noted that while the rejections make note of Iezzi’s relevant teachings regarding certain functional limitations recited in the claims (i.e., “for enhancing immunity”, “wherein the cancer increases an anticancer effect”, “wherein the Prevotella stercorea strain… increases a proliferation of CD4+ T cells and CD8+ T cells”, and “wherein the Prevotella stercorea strain… increases an interferon-γ (IFN-γ) secretion of T cells”) each of these limitations are directed to an inherent property of the Prevotella strain itself, as discussed in the rejection. The opinions and evidence set forth in the declaration do not appear to rebut this presumption of inherency. The declaration only alleges that these effects would not have been expected in view of Iezzi, and does not present evidence to support that these effects are not inherent.
In view of the foregoing, when all of the evidence is considered, the rebuttal evidence fails to overcome the rejections under 35 U.S.C. 102.
Response to Arguments
Regarding the rejection of the claims under 35 U.S.C. 102(a)(1) in view of Iezzi, Applicant merely recites verbatim the same statements made in the declaration under 37 CFR 1.132 filed 08/20/2026, concluding that Iezzi does not anticipate or render obvious the claimed invention.
Applicant’s arguments have been fully considered but they are not persuasive.
The statements made in the declaration have been fully addressed under Response to Declaration. As Applicant merely restates these statements verbatim in their Reply, the examiner considers these arguments to have been fully addressed in the response above. Applicant is advised that a rebuttal against obviousness cannot be used to overcome a rejection under anticipation.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS ARMATO whose telephone number is (703)756-5348. The examiner can normally be reached Mon-Fri 11:00am-7:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DENNIS IGNATIUS ARMATO JR/Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651
Prosecution Insights