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 .
Election/Restrictions
Applicant’s election of Group 1 (claims 1-2, 4-6, 26, 32, drawn to a method of increasing effectiveness of an immune checkpoint inhibitor in a subject comprising administering to the subject the immune checkpoint inhibitor and increasing an amount of one or more bacteria in an intestine of the subject to a therapeutically effective amount) and the species of administration of bacteria before the immune checkpoint inhibitor (claim 5) in the reply filed on 26 Jan 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 6-8, 10-11, 13-17, 19, 22-23, and 29-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (claim 6) or invention (other claims), there being no allowable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.
Claim Status
The amended claim set filed 8 Dec 2023 is acknowledged. Claims 1-2, 4-8, 10-11, 13-17, 19, 22-23, 26, and 29-32 are currently pending. Of those, claims 4, 6, 13, 15-16, 22-23, 26, and 29-32 are currently amended, and no claims are 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 Claims 6-8, 10-11, 13-17, 19, 22-23, and 29-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (claim 6) or invention (other claims), there being no allowable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, 21, 24-25, and 27-28 are cancelled. Claims 1-2, 4-5, 26, and 32 will be examined on the merits herein.
Priority
The instant application claims priority to provisional application 63/208,719 (filed 9 June 2021) and is a 371 of PCT/US2022/032917 (filed 9 June 2022). What follows is the examiner’s claim-by-claim analysis of effective filing date for the claims currently under examination. If the applicant disagrees with this examiner’s determination of effective filing date for any claim, the applicant may identify text within the prior applications that provides support to the claimed language.
Regarding claim 1, the priority application teaches “A method of increasing effectiveness of an immune checkpoint inhibitor in a subject comprising administering to the subject the immune checkpoint inhibitor and increasing an amount of one or more bacteria in an intestine of the subject, wherein the one or more bacteria are selected from the group consisting of bacteria listed in Supplementary Table 4 and Supplementary Table 8 to a therapeutically effective amount.” (‘719 claim 1), but the cited Supplementary Table 4 and Supplementary Table 8 are blurry and difficult to read. Nevertheless, based on optical character recognition of the document, Mogibacterium pumilum does not appear to be present in either of the tables. Supplementary Table 4 appears to only list Mogibacterium diversum instead (see excerpt below). Also, Schaalia odontolytica is only referenced on pg. 36 ln. 28 in a sentence that cites to Supplementary Table 7, rather than Supplementary Table 4 and Supplementary Table 8, so there is not support for using this species in the claimed method. As a third example, Bacteroides thetaiotamicron does not appear to be present in the priority application. There may also be other bacteria not supported by the priority document; this is not a complete listing.
Excerpt from ‘719 Supplementary Table 4:
PNG
media_image1.png
30
316
media_image1.png
Greyscale
Regarding claim 2, Lachnospiraceae spp. bacteria are supported in the priority document (Supplementary Table 4).
Regarding claims 4-5, 26, 32, the new limitations in these claims are supported by ‘719 claims 4-5, 7, pg. 16 ln. 7, and pg. 16 ln. 22, but the claims are not supported for the same reasons as claim 1.
Therefore, the effective filing date used for claims 1, 4-5, 26, and 32 is 9 June 2022 and the effective filing date used for claim 2 is 9 June 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8 Dec 2023 and 16 May 2024 (3x) were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. Signed copies of these statements are attached with this action.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. This is only a notice to applicant, it is not a requirement that the references submitted in the specification be submitted in an IDS.
Drawings
The drawings are objected to because: the figures were created using color and largely cannot be interpreted in a black and white format. A non-limiting set of examples are below, all similar issues with the data legends should be corrected.
Examiner’s view of Figure 1C (partial). The data cannot be matched to the key due to the similarity in color being used.
PNG
media_image2.png
103
420
media_image2.png
Greyscale
Examiner’s view of Figure 1C (partial). The data cannot be interpreted because the key is darker for both increased and decreased values.
PNG
media_image3.png
78
218
media_image3.png
Greyscale
Examiner’s view of Figure 2B (partial). The data cannot be matched to the key due to the similarity in color being used.
PNG
media_image4.png
70
224
media_image4.png
Greyscale
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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) 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).
PNG
media_image5.png
204
606
media_image5.png
Greyscale
Claim Objections
Claim 1 is objected to because of the following informalities: the bacterial species names should be italicized, with a uppercase genus name and a lowercase species name in accordance with the standards in the field. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 4-5, 26, and 32 are 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”, but the term “increasing” is a relative term which renders the claim indefinite because there is no standard provided for comparison. 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,…” but this limitation uses indefinite and relative terms. The term “increasing… to a therapeutically effective amount” is a relative term which renders 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 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.
Also, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The bacteria listed in the present claim 1 include several broader and narrower recitations of bacteria. To provide examples, Anaerostipes is broadly claimed as a whole genus (“Anaerostipes”) but also narrowly claimed as specific species (“Anaerostipes hadrus” “Anaerostipes caccae”). Also, the claim broadly claims the family-level designation “Clostridiaceae bacterium,” but also claims “Dorea” which is a genus within the Clostridiaceae family and also claims “Dorea Unclassified” and “Dorea longicatena” which are narrower classifications within the Dorea genus. This rejection applies to all such examples, not only those listed here. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 2, 4-5, 26, and 32 are also rejected because they depend from claim 1 and do not obviate all rejections above.
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 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gajewski et al. (US 20160354416 A1; hereafter Gajewski; PTO-892) as evidenced by Vacca et al. (2020; PTO-892).
Regarding claims 1, 2, 4, 26, Gajewski teaches “methods of treating or preventing cancer in a subject, comprising modulating levels of one or more commensal microbes within the subject to: (A) enhance an immune response by the subject, (B) inhibit the growth or spread of the cancer, (C) inhibit immune evasion by the cancer, and/or (D) enhance the efficacy of a therapeutic.” [0005]. Gajewski teaches administering commensal microbes (i.e. increasing) in order to achieve the modulation, and teaches that the bacteria administered could be Butyrivibrio, Eubacterium, Ruminococcus, or Anaerostipes, which are all part of Lachnospiraceae (see definition of the term from Vacca et al. in par. 16). Alternately, Gajewski teaches administering (i.e. increasing) Bifidobacterium bifidum in an example [0141]. In addition to the bacteria, Gajewski teaches further administering to the subject a cancer therapy, including administration of anti-PD-L1 or anti-PD-1 antibodies (i.e. immune checkpoint inhibitors).
Regarding claim 5, Gajewski teaches “In some embodiments, the immune checkpoint inhibitor is administered after the bacterial formulation.” [0016].
Regarding claim 32, Gajewski teaches “In some embodiments, the subject is human.” [0014].
Conclusion
No claims are allowed.
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).
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, 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.
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.
/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
Prosecution Insights