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 .
Claim Status
The amended claim set filed 4 Aug 2026 is acknowledged. Claims 1-2, 4-8, 10-11, 13-17, 19, 22-23, 26, and 29-33 are currently pending. Of those, claim 1 is currently amended, and claim 33 is new. Claims 6-8, 10-11, 13-17, 19, 22-23, and 29-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (claim 6) or invention (other claims), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 26 Jan 2026. Claims 3, 9, 12, 18, 20-21, 24-25, and 27-28 are cancelled. Claims 1-2, 4-5, 26, and 32-33 will be examined on the merits herein.
Response to Arguments
The Applicants’ arguments filed 4 Aug 2026 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 5 May 2026 will be referred to as “NFOA.”
Priority
The Remarks do not dispute the priority findings from the NFOA. Therefore, the effective filing date used for claims 1, 4-5, 26, and 32 remains 9 June 2022 and the effective filing date used for claim 2 remains 9 June 2021.
Claim Interpretation
Regarding the definition of the claim term “Lachnospiraceae” recited in claims 1-2, the bacterial genera within this grouping are not specifically defined in the specification. Vacca et al. (2020; PTO-892 mailed 5 May 2026) is a review article that teaches the understanding of the term in the art at the time of filing, see Figure 1 which includes a summary of the genera within the family (copied below). The interpretation of the term from the art will be used in this action.
Vacca et al. Figure 1 (partial).
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Objection(s) and Rejection(s) Withdrawn
The objection to claim 1 is withdrawn in view of the claim amendments.
The rejection of claims 1-2, 4-5, 26, and 32 related to the broader and narrower ranges of bacteria (NFOA par. 21) is withdrawn in view of the claim amendments.
The rejection of claims 1-2, 4-5, 26, and 32 under 35 U.S.C. 102(a)(1) as being anticipated by Gajewski et al. (NFOA par. 23-26) is withdrawn in view of the claim amendments to remove from claim 1 Bifidobacterium bifidum, Lachnospiraceae, Lachnospiraceae bacteria, and Anaerostipes. The argument that there is not an enabling disclosure for strains other than B. bifidum is not found persuasive because no evidence was provided that one of ordinary skill in the art at the time of filing would have believed “an enabling example of altering levels of other bacterial species” (Remarks pg. 19, emphasis added) is required for an enabling disclosure.
Objection(s) and Rejection(s) Maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Drawings
The drawings are objected to because: the figures were created using color and largely cannot be interpreted in a black and white format.
Response to Arguments
Applicant argues (Remarks pg. 17) that applicants have submitted replacement drawings corrected the issues with a petition to accept color drawings.
The objection is maintained because the Office has not yet decided whether the petition will be accepted, but the replacement drawings filed 8 Aug 2026 would overcome the objection if the petition is accepted.
Claim Rejections - 35 USC § 112(b)
Claims 1-2, 4-5, 26, and 32 remain rejected and claim 33 is newly rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim recites “increasing effectiveness of an immune checkpoint inhibitor in a subject relative to a control”, but the terms “increasing” and “control” are relative terms which render the claim indefinite because there is no standard provided for comparison. The term “control” is generic and the broadest reasonable interpretation could be any value. Therefore, the term “increasing” and is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In the interest of compact prosecution, in this action the claim will be interpreted as any amount of efficacy of the immune checkpoint inhibitor meets the intended use in the preamble.
Also, the claim recites “increasing an amount of one or more bacteria in an intestine of the subject to a therapeutically effective amount relative to a control,…” but this limitation uses indefinite and relative terms. The terms “increasing… to a therapeutically effective amount” and “control” are relative terms which render the claim indefinite. The actions encompassed in “increasing” are not defined by the claim or the specification, and also the claims and specification do not define how one has determined whether the increase reaches “a therapeutically effective amount”. The term “control” is generic and the broadest reasonable interpretation could be any value. The terms “increasing” and “a therapeutically effective amount” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In the interest of compact prosecution, in this action the claim will be interpreted as any subject comprising any amount of the claimed bacterial species and where the immune checkpoint inhibitor therapy is successful has inherently performed the “increasing” step, due to the dietary and lifestyle choices the subject made to shape their microbiome, thereby performing an action to increase the bacteria to an amount where the immune checkpoint inhibitor therapy has effectiveness.
Claims 2, 4-5, 26, and 32-33 are also rejected because they depend from claim 1 and do not obviate all rejections above.
Response to Arguments
Applicant argues (Remarks pg. 17-18) that claim 1 has been amended to include comparison to a control as a reference level and points to a definition of the term at page 7 paragraph [0049], "The term "increased" or "increase" as used herein generally means an increase by a statistically significant amount for the avoidance of any doubt, "increased" means an increase of at least 10% as compared to a reference level...".
This argument has been carefully considered but is not found persuasive. Neither the claims nor spec define what the control is, so the claims still recite increases compared to a generic, unknown value. The cited definition does not define the reference level.
New Rejection(s)
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-2, 4-5, 26, and 32-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kovarik et al. (US 20170173085 A1; hereafter Kovarik; PTO-892) as evidenced by Vacca et al. (2020; PTO-892 mailed 5 May 2026).
Regarding claims 1-2, 4, 33, Kovarik teaches administering to the subject an immune checkpoint inhibitor and a bacterial formulation [0173]. Kovarik teaches that the bacteria administered can be from the genus Eubacteria [0023, 0045], and teaches that Eubacterium rectale is one of the two most important bacteria producing butyrate, which is beneficial for cancer treatment by impeding colorectal cancer cell proliferation [0081]. Vacca et al. provides evidence that Eubacterium is a Lachnospiraceae spp. (Vacca et al. Figure 1, also copied above). Regarding the functional limitations relating to the in vivo effects, MPEP 2112.01 states: “"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). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.” The Eubacterium rectale and immune checkpoint inhibitor are the same products that are claimed and they are used in Kovarik in the same way that is claimed, so the products’ properties that result in the claimed functional effects are also inherently disclosed.
MPEP 2112.01 states: “"When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.”
Regarding claim 5, “In some embodiments, the immune checkpoint inhibitor is administered at least one day after the bacterial formulation” [0173].
Regarding claim 26, the immune checkpoint protein being inhibited can be PD-1 or PD-L1 [0173].
Regarding claim 32, the subject can be human [Abstract].
Claims 1-2, 4-5, 26, and 32-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grant et al. (US 20170360856 A1; hereafter Grant; PTO-892) as evidenced by Vacca et al. (2020; PTO-892 mailed 5 May 2026) and Kwok et al. (2016; PTO-892).
Regarding claim 1-2, 4, 33, Grant teaches administering Blautia wexlerae to reduce the severity of the inflammatory response [0006] and that the invention is useful in treating or preventing cancer [0161]. Vacca et al. provides evidence that Blautia is a Lachnospiraceae spp. (Vacca et al. Figure 1, also copied above). Grant teaches that “the invention provides a composition comprising a bacterial strain of the genus Blautia and an anticancer agent. In preferred embodiments the anticancer agent is an immune checkpoint inhibitor” and gives the example of Keytruda™ (pembrolizumab) [0169]. Regarding the functional limitations relating to the in vivo effects, MPEP 2112.01 states: “"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). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.” The Blautia wexlerae and immune checkpoint inhibitor are the same products that are claimed and they are used in Grant in the same way that is claimed, so the products’ properties that result in the claimed functional effects are also inherently disclosed.
MPEP 2112.01 states: “"When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.”
Regarding claim 5, Grant teaches that administering Blautia wexlerae is useful to prevent cancer [0161] so it would be administered before the immune checkpoint inhibitor that is a cancer therapy [0169].
Regarding claim 26, Kwok provides evidence that Keytruda™ (pembrolizumab) is an anti-PD1 antibody (Abstract).
Regarding claim 32, Grant teaches treating humans [0180].
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIA N DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-F 8:30-4:30 (EDT/EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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AMELIA N DICKENS
Examiner
Art Unit 1645
/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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