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 .
Status of Claims
Claims 1, 3 and 6-14 are pending following the Reply filed 04/28/2026 and have been examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) filed 04/28/2026 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 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 the limitation of a “method for enhancing immunity”. 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 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, 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). Hence, Iezzi teaches the strain increases an anticancer effect.
Regarding claim 6, Iezzi 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. Iezzi further teaches a pharmaceutical composition comprising one of the bacteria specified in Table 3A that is administered concomitant (together) with an immune checkpoint inhibitory agent (see pg. 12, lines 23-27). 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, in another embodiment, Iezzi 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, 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.
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 Iezzi that are discussed above. See MPEP 2112.
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.
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 Iezzi, 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 Iezzi that are discussed above. See also MPEP 2112 and the discussion regarding claim 12 above.
Regarding claim 14, Iezzi teaches the bacterium is provided for preventing cancer, particularly colorectal cancer (see pg. 5, lines 18-19).
Response to Arguments
Regarding the rejection of the claims under 35 U.S.C. 102(a)(1) in view of Iezzi, Applicant argues that the claimed invention is drawn to the use of Prevotella stercorea KCTC15079 alone, and the present inventors have demonstrated that an immune-enhancing effect can be exhibited by using a culture supernatant of Prevotella stercorea, and that therapeutic effect can be significantly increased by administering the Prevotella stercorea strain in combination with an anti-PD-1 monoclonal antibody.
Applicant’s arguments have been fully considered but they are not persuasive.
The claims in their present form recite a method comprising administering a composition comprising a Prevotella stercorea strain or a culture solution thereof. Here, the claims recite the method using open language, and none of the limitations exclude the administering of other elements. Therefore, the claims do not require administering the Prevotella stercorea strain “alone”, and the administering of “a culture supernatant thereof” is recited in the alternative. Furthermore, Iezzi explicitly teaches a pharmaceutical composition comprising the bacterial strain that is administered with an inhibitor of PD-L1, as discussed in the rejection.
Applicant further argues that the claimed invention has an inventive step that cannot be easily inferred from Iezzi, because Iezzi does not describe, suggest or demonstrate that the Prevotella strain can promote T cell proliferation and an immune response, and that the strain alone can enhance an anticancer effect when administered in combination with an immune checkpoint inhibitor. Applicant discusses Example 6 of Iezzi, where the experiment was conducted by treating colorectal cancer (hereinafter, "CRC") cells with Fusobacterium nucleatum, Bacteroides fragilis, and Escherichia coli in order to determine whether expression of chemokines is promoted by bacteria. Therefore, the bacteria directly demonstrated to promote secretion of chemokines are the above three species, and that the strain of the present invention is not included therein.
Applicant’s arguments have been fully considered but they are not persuasive.
First, Applicant’s argument that “an inventive step” must somehow be “easily inferred” from Iezzi’s disclosure is not germane to the rejection at issue, because the alleged presence of “an inventive step” is probative of non-obviousness, while the claims have been anticipated.
Applicant is reminded that“[t]he 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). See MPEP 2123.
In the instant case, Iezzi expressly teaches embodiments which include administering the bacterial strain of the instant claims to treat cancer. The fact that the reference teaches other embodiments or exemplifies other species does not negate the use of the reference for the embodiments relied upon in the rejection. Furthermore, any argument that the anticipatory prior art allegedly “teaches away from the invention” is not germane to a rejection under section 102. Twin Disc, Inc. v. United States, 231 USPQ 417, 424 (Cl. Ct. 1986) (quoting In re Self, 671 F.2d 1344, 213 USPQ 1, 7 (CCPA 1982)). Applicant is also reminded that "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).
Applicant further argues that in Iezzi’s experiments chemokine expression was higher in cecal tumors than in intraperitoneal tumors, and that chemokine expression in cecal tumors was reduced when antibiotics were administered, thereby confirming that commensal bacteria are major inducers of chemokines in CRC. Further, the bacterial groups reduced by the antibiotics were Bacteroidetes and Firmicutes, and the strains described as having statistically significant correlations with chemokines (CCL5, CCL20, and CXCLl1), which had been statistically significantly increased in the tumor mouse model in which CRC cells were injected into the cecum, were Rikenellaceae, Ruminococcace, and Lachnospiracee. Applicant concludes there is no “direct disclosure” regarding the strain of the claimed invention.
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant is reminded that “[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). In the instant case, Iezzi explicitly (“directly”) discloses that the claimed Prevotella strain was “identified” as being “associated with T cell recruitment in tumor tissues and improved prognosis” by its inclusion in Table 3A (see pg. 16, Table 3A), and this strain is included in Iezzi’s embodiments. The fact that the reference teaches other embodiments or exemplifies other species does not negate the use of the reference for the embodiments relied upon in the rejection.
Applicant further argues that the experiments above merely confirm that chemokine expression differs between tumors formed in the cecum and those formed in the intraperitoneal cavity, and from this infers that commensal bacteria in the intestine may regulate chemokine expression within tumor tissues. However, considering that tumors present in different tissues may operate through different mechanisms depending on their surrounding environments, a person of ordinary skill in the art would clearly understand that this does not establish the ability of intestinal commensal bacteria to regulate chemokine expression within tumor tissues.
Applicant’s arguments have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the ability to regulate chemokine expression within tumor tissues) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant is also reminded that "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). This is discussed further below.
Applicant argues that Iezzi does not disclose any specific Example demonstrating that administration of the Prevotella stercorea strain can enhance an immune response and treat cancer. The only portion in Iezzi relating to the effect of the Prevotella stercorea strain is the disclosure in Example 7 described above, namely, that the abundance of the relevant strain was increased in CD3low tumors. Applicant argues that in biotechnology inventions, the asserted effects must be supported by Examples. However, Iezzi does not demonstrate, even in vitro, that the Prevotella can enhance anticancer effects when administered in combination with an immune checkpoint inhibitor.
Applicant’s arguments have been fully considered but they are not persuasive.
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)). 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) (Emphasis added).
In the instant case, Applicant’s argument fails to provide any evidence that a person of ordinary skill would not have been able to carry out the claimed method (i.e., to have administered a composition comprising a Prevotella stercorea strain to a subject having cancer) without the aid of the present disclosure. It should be noted that when rebutting the presumption of operability, the question is whether or not the skilled artisan would have been able to carry out the prior art invention, not whether the prior art reference disclosed the same results that were achieved by the present inventors.
Applicant argues that it would not have been obvious and possible to predict an anticancer treatment enhancing effect of the Prevotella stercorea strain merely from the experimental results confirming that chemokine expression was increased in cecal tumors, or that TIL infiltration was increased, together with the fact that the abundance of the Prevotella was high in CD3low tumors.
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant is reminded that “obviousness” and “predictability” are properly considered under 35 U.S.C. 103, while the present claims are rejected under 35 U.S.C. 102 as being anticipated by the prior art reference.
Regarding the experimental results disclosed by Iezzi, "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)).
In the instant case, Iezzi clearly teaches methods which include administering the Prevotella stercorea strain for its anti-tumor effects. The extent to which Iezzi demonstrated these effects experimentally is not germane to the rejection at issue, so long as Iezzi taught each of the claimed elements, and a person of skill would have been able to carry out the method as claimed. As the features of the claimed invention are expressly taught by Iezzi, any argument as to whether or not it was “possible to predict” that this method would achieve the same “anticancer treatment enhancing effect” disclosed by the present inventors is irrelevant to the rejection at issue.
Applicant cites that the prior art of Wang et al. (cited in the IDS filed 04/28/2026) which discloses that Enterococcus faecalis may have the potential to induce colorectal cancer. Accordingly, a person of ordinary skill in the art would have clearly recognized from Wang et al. that it could not have been predicted that the strains disclosed in Iezzi, i.e., strains whose abundance was altered within tumors, could be used for anticancer treatment. Therefore, even assuming that Prevotella stercorea provides a motivation that it is associated with an immune response of tumors, it is clear that the effect thereof falls within an unpredictable field, and there is no reasonable expectation of success.
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant is reminded that factors such as predictability, motivation and expectation of success are properly considered under 35 U.S.C. 103, and arguments pertaining to these factors are typically not germane to overcoming rejections under anticipation. Here, the question as to 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). It should also be noted that the prior art of Wang, et al. does not discuss any subject matter pertaining to species of Prevotella.
Applicant argues that the therapeutic effect of Prevotella stercorea within a microbial community whose abundance was increased in tumor tissues cannot be considered to show inherency, because inherency must be a necessarily occurring result. However, Iezzi does not demonstrate that Prevotella stercorea affects T cell infiltration, nor is there any demonstration anywhere that such effect is inevitable. Here, there is no evidence that a skilled artisan recognizes such effects and that such effects are necessarily present.
Applicant further recites the MPEP and related case law in making this argument: It is plain that "[t]he fact that certain result or characteristic may occur or be present in the prior art is not sufficient to establish the inherency of the result or characteristic." See MPEP §2112.IV (citing In re Rijckaert, 9 F.3d 1531 (Fed. Cir. 1993)) (emphasis in original). To be inherently disclosed by a prior art reference, a limitation "must be necessarily present and a person of ordinary skill in the art would recognize its presence." See, e.g., Crown Operations Int'l, Ltd. v. Solutia, Inc., 289 F.3d 1367, 1377 (Fed.Cir. 2002).
Applicant’s arguments have been fully considered but they are not persuasive.
"In relying upon the theory of inherency, the examiner must provide a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art." Ex parte Levy, 17 USPQ2d 1461, 1464 (Bd. Pat. App. & Inter. 1990) (emphasis in original). In the instant case, inherency is based on the structural similarity between the claimed and prior art bacterial strains. Applicant has made no argument that Iezzi does not teach the same bacterial strain for the treatment of cancer. Therefore, the basis in fact and/or technical reasoning to support inherency is that the structure of the administered bacteria of the claims is the same as those in the prior art, and these effects are deemed to be necessarily present when administering this strain of bacterium. "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).
Furthermore, there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency) (Emphasis added); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) ("[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention.") (Emphasis added). In the instant case, inherent anticipation does not require the prior art to have disclosed or to have demonstrated the underlying properties which give rise to the bacterium’s therapeutic effects, or for any of these properties to have been known before the time of filing.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999) (Emphasis added). In the instant case, Applicant alleges the discovery of certain underlying mechanisms and/or unappreciated properties which give rise to the usefulness of the claimed bacterium for treating cancer. However, this discovery does not change the fact that the prior art already teaches the administration of the same bacterium for the same purpose of treating cancer. In the absence of any evidence (or argument) that these bacterial strains were not the same, the effects of the claimed method are necessarily present in the anticipatory prior art.
Applicant further argues that when bacteria disclosed in Iezzi as being related to combination administration with an immune checkpoint inhibitor are reviewed, it can be confirmed that Prevotella is not disclosed among such bacteria (see “Table 1c”). That is, Iezzi does not disclose any combination administration effect of Prevotella with an immune checkpoint inhibitor, and it is considered that predicting an anticancer therapeutic effect through combination administration with an immune checkpoint inhibitor from Iezzi would also not have been obvious and easy.
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant is reminded that factors such as predictability, motivation and expectation of success are properly considered under 35 U.S.C. 103 (obviousness), and arguments pertaining to these factors are typically not germane to overcoming rejections under anticipation.
Furthermore, Applicant’s argument presents inconclusive evidence (“Table 1c”) while ignoring the remainder of Iezzi’s disclosure. Iezzi explicitly recites embodiments where the claimed strain is taught to be used for a combination therapy with a checkpoint inhibitor. For example:
The pharmaceutical composition for the treatment or prevention of cancer according
to item 7 or 8, wherein said pharmaceutical composition comprises one or several of
the kinds of bacteria specified in any one of Tables 1A, 1C, 2A, 2C, 3A and 3C and is
administered concomitant with administration of a checkpoint inhibitory agent or
checkpoint agonist agent. (see pg. 12, lines 23-27)
Here, Table 3A expressly includes Prevotella stercorea DSM 18206 (see pg. 17). Furthermore, Table 1C is labelled “identified bacterial genera (monotherapy or checkpoint modulator combination)” (see pg. 14; Emphasis added). Hence, the evidence Applicant relies upon in this argument is questionable, because the bacteria of Table 1C are not excluded from monotherapies, just as the bacteria of Table 3A are not excluded from combination therapies. In fact, the bacteria of Table 3A are expressly included for use in combination therapies. Therefore, the disclosure does not limit combination therapies with a checkpoint inhibitor to the genera recited in Table 1C as Applicant appears to argue.
Applicant further argues that a person of ordinary skill in the art would not have attempted to use the Prevotella strain, which abundance increased in CD3low tumors, for immune enhancement or for enhancing anticancer effects when administered in combination with an immune checkpoint inhibitor, and even assuming such an attempt were made, the effect would not have been within a reasonably predictable range.
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant is reminded that factors such as predictability, motivation and expectation of success are properly considered under 35 U.S.C. 103 (obviousness), and arguments pertaining to these factors are not typically germane to overcoming rejections under anticipation. Specifically, the argument that an ordinary artisan “would not have attempted” the claimed invention or the effects of doing so “would not have been within a reasonably predictable range” are irrelevant, because the present claims are anticipated by a prior art reference that is presumed to be operable and teaches all of the claimed elements.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/DENNIS IGNATIUS ARMATO JR/Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651
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