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 17-18, 20-24 and 26-44 are pending following the Reply filed 05/04/2026. Claims 45-46 have been cancelled. Claims 17, 20, 23 and 26 have been amended without introducing new matter. Claims 28-44 are withdrawn. Claims 17-18, 20-24 and 26-27 have been examined on the merits.
Information Disclosure Statement
The information disclosure statements filed on 02/06/2026, 03/04/2026 and 06/05/2026 have been considered by the examiner.
Withdrawn
Any objection or rejection of claims 45-46 is moot because the claims are cancelled.
The objection of claim 26 is withdrawn in light of the amendments.
The rejections of claims 17-18, 20-24 and 26-27 under 35 U.S.C. 112(b) are withdrawn in light of the amendments.
Maintained rejections and new rejections necessitated by amendment
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.
Claim(s) 17-18, 21-24 and 27 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ravichandar, et al. (U.S. 2023/0031818 A1; effectively filed 01/17/2020; cited on Form 892), hereafter, “Ravichandar”.
Regarding claim 17, Ravichandar teaches a method for treating colorectal cancer in a subject, the method comprising administering to the subject a composition comprising an effective amount of a bacterial species selected from the group that includes Barnsiella intestinihominis (see claim 6), wherein the bacterial species Barnsiella intestinihominis comprises the strain Barnsiella intestinihominis DSM 21032 (see claim 26), wherein the Barnsiella intestinihominis DSM 21032 has a 16S RNA gene according to SEQ ID NO: 44 (see claim 86). Ravichandar teaches the composition further comprising a stabilizer (see pg. 26, para. [0204]) and/or one or more cryopreservants (see claim 164).
As shown in the following alignment, Ravichandar’s SEQ ID NO: 44 (bottom) has at least 98.7% sequence identity with instant SEQ ID NO: 9 (top):
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Note that that the alignment shows the sequences to have 1517/1536 base pair matches, which makes Ravichandar’s sequence 98.76% identical to instant SEQ ID NO: 9.
Regarding the limitation, “a faecal sample obtained from one or several individual(s)”, Ravichandar teaches that the composition comprises a bacterial strain that is isolated (see pg. 26, para. [0208]), and the term “isolated” in reference to a microbe is intended to mean that the microbe has been separated from at least one of the materials with which it is associated in a particular environment, for example, gastrointestinal fluid or tissue (see pg. 13, para. [0111]). Ravichandar teaches the method further comprising the step of detecting a dysbiosis associated with colorectal cancer in a sample from the subject (see claim 6), wherein the sample is a fecal sample (see claim 7), wherein the detection comprises determining that Barnesiella intestinihominis is decreased in the subject (see claim 13). Therefore, it is understood in view of Ravichandar’s disclosure that this particular bacterium is a fecal bacterium that can be obtained from human feces.
Nonetheless, this limitation is directed to a product-by-process step which does not alter the minimal structure required by the claim. In the instant case, there is no patentable difference between a composition comprising a “faecal sample” comprising the bacterium obtained from one or several individual(s) when compared to a composition comprising the bacterium itself, because the “faecal sample” is only recited as comprising the bacterium without any further structure required by the claim. See MPEP 2113.
Regarding the limitation, “wherein the presence or relative abundance of one or more bacteria as a proportion of the total microbiota in a sample is associated with a response to cancer with a checkpoint inhibitor therapy”, Ravichandar teaches the method further comprising administering another treatment to the subject (see claim 177), wherein the treatment comprises a therapeutic agent (see claim 182), wherein the therapeutic agent comprises an immunotherapy (see claim 183), wherein the immunotherapy comprises a checkpoint inhibitor (see claim 187). Therefore, it is understood in view of Ravichandar’s disclosure that the bacterium is associated with a checkpoint inhibitor therapy.
Nonetheless, this limitation refers to an inherent property of the bacteria themselves and is satisfied by the presence of the recited bacteria in the composition without requiring any further structure to said composition. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "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, Ravichandar teaches the composition comprising the same bacteria as the claim, which are inherently associated with a response to checkpoint inhibitor therapy.
Thus, Ravichandar teaches a composition comprising a faecal bacterium and one or more stabilizers and/or cryoprotectants, wherein the composition has a presence of bacteria having at least 98.7% sequence identity with instant SEQ ID NO: 9, which meets the claim.
Regarding claim 18, Ravichandar teaches the method wherein the bacterial strain is lyophilized (see claim 163).
Regarding claim 21, Ravichandar teaches the method wherein the composition is formulated as a tablet, a capsule or liquid (see claim 173).
Regarding claim 22, Ravichandar teaches the method wherein the checkpoint inhibitor targets one or more of PD-1, PDL-1, TIM-3, LAG-3 or CTLA-4. However, as discussed regarding claim 17, this limitation refers to an inherent property of the bacteria themselves and is satisfied by the presence of the recited bacteria in the composition.
Regarding claim 23, Ravichandar teaches a composition comprising a faecal bacterium and one or more stabilizers and/or cryoprotectants, wherein the composition has a presence of bacteria having at least 98.7% sequence identity with instant SEQ ID NO: 9, as discussed regarding claim 17. Regarding the limitation, “wherein said faecal sample has been supplemented”, this limitation is a product-by-process step which does not change the structure of the claimed product when compared to the composition of claim 17.
Regarding the limitation of a “relative abundance… as a proportion of the total microbiota in a sample”, the instant claim does not recite what proportion (e.g., percentage) of the sample is required to be represented by the claimed bacteria, and therefore, any abundance may be considered to be “a relative abundance” as a proportion of the total microbiota in the sample. In the instant case, Ravichandar teaches the method wherein the effective amount of the bacterial strain comprises about 1x106-1x1010 CFU of the bacterial strain (see claim 167). It should also be noted that Ravichandar’s claims do not require the composition to comprise more than one bacterium, and Ravichandar teaches the isolated microbes may exist as isolated and biologically pure cultures (see pg. 13, para. [0112]). Hence, Ravichandar reasonably teaches the selected bacterium to have a “relative abundance” as a proportion of the total microbiota in the composition, which meets the claim.
Regarding claim 24, Ravichandar teaches the method wherein the bacterial strain is lyophilized (see claim 163).
Regarding claim 27, Ravichandar teaches the method wherein the composition is formulated as a tablet, a capsule or liquid (see claim 173).
Claim(s) 17, 20 , 23 and 26 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ford, et al. (U.S. Patent 12,214,002 B2; effectively filed 10/30/2017; previously cited), hereafter, “Ford”, as evidenced by Santiago (previously cited).
Regarding claim 20, Ford teaches a composition prepared from bacteria that are isolated from stool (see col. 6, lines 55-57), the composition comprising 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, or 14 species listed in Table 3 (see col. 2, lines 27-29), which includes SEQ ID NO: 270 (see Table 3, col. 23, “Lachnospira_pectinoschiza”) and SEQ ID NO: 259 (see Table 3, col. 23, “Roseburia_faecis”).
As shown in the following alignment, Ford’s SEQ ID NO: 270 (bottom) shares more than 98.7% sequence identity with instant SEQ ID NO: 12 (top):
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Note that that the alignment shows the sequences to have 1518/1530 base pair matches, which makes Park’s sequence 99.2% identical to instant SEQ ID NO: 12.
As shown in the following alignment, Ford’s SEQ ID NO: 259 (bottom) shares more than 98.7% sequence identity with instant SEQ ID NO: 14 (top):
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Regarding the limitation of “one or more stabilisers and/or cryoprotectants”, Ford teaches the composition further comprises one or more pharmaceutical excipients which may include sucrose, gelatin, glycerol, and/or polyethylene glycol (see col. 12, lines 16-18, 35-40). In view of Santiago, sucrose, gelatin, glycerol, and polyethylene glycol are all cryoprotectants, which are substances added to a formulation in order to protect an active ingredient during freezing (see pg. 52, para. [0202]). Hence, the excipients taught by Ford meet the claimed limitation of “one or more cryoprotectants”, as evidenced by Santiago. See MPEP 2131.01 which states extra references can be used to show the meaning of a term used in the primary reference.
Hence, Ford discloses every element required by claim 20.
Regarding claim 26, the limitation, “wherein said faecal sample has been supplemented”, recited in claim 23 (from which claim 26 depends), is a product-by-process step which does not change the structure of the claimed product. Hence, Ford discloses every element required by claim 26, as presented above regarding claim 20.
Response to Arguments
Regarding the rejections under 35 U.S.C. 102 in view of Schneider et al. (U.S. Patent 9,999,641; "Schneider"), Applicant argues that claims 17, 20, 23, and 26 have been amended herein to remove recitations of SEQ ID NO: 8, thereby overcoming this rejection.
Applicant’s arguments have been considered but are moot because the new ground of rejection, which was necessitated by Applicant’s amendments to the claims, 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 rejections under 35 U.S.C. 102 in view of Ford et al. (U.S. Patent 12,214,002; "Ford") as evidenced by Santiago et al. (US 2024/0307460; "Santiago"), Applicant argues that claims 17, 20, 23, and 26 have been amended herein to remove recitations of SEQ ID NOs: 1 and 7, thereby overcoming this rejection.
Applicant’s arguments have been considered but are moot because the new ground of rejection, which was necessitated by Applicant’s amendments to the claims, does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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