Roud DETAILED ACTION
Status of Application
Claims 17, 21, 23-27, 31, 33, 37, 39 are pending
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
The following amendments, additions, and cancelations as submitted on 10/10/2025 are acknowledged:
Claims 1-16, 18-20, 22, 28-30, 32, 34-36, and 38 are cancelled.
Claims 17, 27, 33, are amended.
Claim 39 is added.
Claims 17, 21, 23-27, 31, 33, 37, and 39 are being examined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/10/2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification Objections
The previous objection of the specification due to the recitation of “…bacteria was supplied to the mice through oral gavage 3 weeks a week, for a total of 4 weeks…”(specifications filed 06/21/2023, [96]) is hereby withdrawn by virtue of Applicant’s amendment.
Claim Objections
Applicant is advised that should claim 17 be found allowable, claim 39 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112(a)
Claims 17-38 were previously rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification did not reasonably provide enablement for a method of preventing or treating a brain tumor by administering a pharmaceutically effective amount of a composition comprising at least one selected from the group consisting of a Desulfovibrionaceae family strain, a culture thereof, a culture medium, and an extract obtain therefrom. In view of the amendment of claims 17, 27, 33, and the cancellation of claims 18-20, 22, 28-30, 32, 34-36, and 38, the rejections are hereby withdrawn.
Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA )
(previous rejection, withdrawn) Claims 17-21, 23-31, and 33-37 were previously rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing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. In view of the amendment of claims 17, 27, 33, and the cancellation of claims 18-20, 22, 28-30, 32, 34-36, the rejections are hereby withdrawn.
Claim Rejections - 35 USC § 102 (AIA )
Claims 17, 21, 27, 31, 33, and 37 were previously rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sears, WO 2019169202 A1 (see form PTO-892 Notice of References Cited posted on 07/11/2025).
Response to Arguments
Applicant’s arguments with respect to the rejections of claims 17, 21, 27, 31, 33, and 37 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Applicant has amended claim 17, 27, and 33, to recite “consumes more than 0.02 g/kcal as a ratio of the total daily sugar intake to a total daily caloric intake for at least five weeks at the time of the administration”, rendering the rejections of 17, 21, 27, 31, 33, and 37 moot. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground of rejections are made in view of Applicant’s amendment of claims 17, 27, and 33.
Claim Rejections - 35 USC § 103 (AIA )
Claims 17, 21-22, 27, 31-33 and 37-38 were rejected under 35 U.S.C. 103 as being unpatentable over Sears as applied to claims 17, 21, 27, 31, 33, and 37, and in view of Lezzi, WO 2019149859 A1 (see form PTO-892 Notice of References Cited posted on 07/11/2025).
Claims 17, 21-27, 31-33 and 37-38 were rejected under 35 U.S.C. 103 as being unpatentable over Sears and Iezzi as applied to claims 17, 21-22, 27, 31-33 and 37-38 above, and further in view of Luksik (see form PTO-892 Notice of References Cited posted on 07/11/2025).
Response to Arguments
Applicant’s arguments, with respect to the rejections of claims 17, 21-27, 31, 33 and 37 under 35 U.S.C. 103 have been fully considered and are persuasive. Applicant has amended claims 17, 27, 33, rendering the rejections of 17, 21-27, 31, 33 and 37 moot. In addition, the Applicant has canceled claims 22, 32, and 38 rendering the rejection of claim 22, 32, and 38 moot. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Applicant’s amendment of claim 17, 27, and 33.
(new rejection, necessitated by amendment and addition) Claims 17, 21, 27, 31, 33, 37, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over unpatentable over Sears et al., WO 2019169202 A1 (see form PTO-892 Notice of References Cited posted on 07/11/2025; hereby “Sears”), in view of Busi et al. (American Association for Cancer Research Annual Meeting Published 04/14/2018; hereby “Busi”), in further view of Makarem et al. (Annual review of nutrition 38.1 (2018): 17-39.; hereby “Makarem”), and evidenced by Amos-Landgraf et al. (Research square published 2022; hereby “Amos”).
The teachings of Sears have been discussed in the 07/11/2025 office action.
Regarding claims 17, 21, 27, 31, 33, 37, and 39 Sears teaches a method of treating cancer in a subject comprising administering a therapeutically effective amount of a pharmaceutical composition or an edible composition (which is a food) comprising Desulfovibrio bacteria (Sears, claims 1, 2, 15; pg. 35, ln 5-15). Sears additionally teaches that this method may be used for the treatment of brain tumors. Sears teaches that the brain tumors treated by the method include Meningiomas, Glioblastomas, Lower-Grade Astrocytomas, Oligodendrocytomas, Pituitary Tumors, Schwannomas, and Metastatic brain cancers (Sears, pg. 7, ln 6-15; pg. 29, ln 12-18).
Sears does not explicitly teach a composition comprising of Desulfovibrio vulgaris. Sears does not a method for treating a brain tumor wherein the subject consumes more than 0.02 g/kcal as a ratio of the total daily sugar intake to a total daily caloric intake for at least five weeks at the time of the administration.
Busi teaches that DvH significantly reduced colonic adenoma size in rats after the rats were gavaged with isolates of DvH (abstract). DvH is Desulfovibrio vulgaris as evidenced by Amos (abstract).
Makarem teaches associations between dietary sugars and lifestyle-related cancer risk from longitudinal studies (abstract). Makarem teaches that compared to participants who did not consume soft drinks, participants who consumed
>6 cans/week of soft drinks had an 83% higher risk of biliary tact cancers (Page 29 [4]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Sears, Busi, and Makarem to treat brain tumors with the claimed method. A person of ordinary skill in the art is motivated to treat a brain tumor by administering D. vulgaris to a subject that consumes more than 0.02 g/kcal as a ratio of the total daily sugar intake to a total daily caloric intake for at least five weeks at the time of the administration, because Busi demonstrates that D. vulgaris possesses anti-tumor capabilities. A person of ordinary skill in the art would have recognized the strain disclosed by Busi and substituted the Desulfovibrio bacteria of Sears with D. vulgaris with a reasonable expectation that the anti-tumor activity of D. vulgaris would be beneficial in the methods of Sears. Furthermore, Makarem teaches that subjects with high sugar intake levels can have an increased risk of cancer. Accordingly, one of ordinary skill in the art would have been motivated to administer D. vulgaris to a subject having a high daily sugar diet for a prolonged time since Desulfovibrio bacteria, specifically D. vulgaris, have been used to treat cancer, and subjects having a high sugar diet have an increased risk to cancer and mortality. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
(new rejection, necessitated by amendment) Claims 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Sears, Busi, and Makarem as applied to claims 17, 21, 27, 31, 33, 37, and 39 above, and further in view of Luksik et al. (see form PTO-892 Notice of References Cited; “Luksik” posted on 07/11/2025) and Lezzi et al. (see form PTO-892 Notice of References Cited posted on 07/11/2025).
The teachings of Sears, Busi, and Makarem have been discussed above. The obviousness to combine Sears, Busi, and Makarem have been discussed above. The combination of Sears, Busi, and Makarem does not explicitly teach the immune checkpoint inhibitors as recited in the methods of claims 23-26.
Lezzi teaches a method of treating and preventing cancer by administering a composition comprising Desulfovibrio bacteria (Iezzi, claim 1). Regarding claim 26, Lezzi also discloses that Desulfovibrio strains are associated with T cell recruitment in tumor tissues and improved prognosis (Lezzi, Tables 2A, 3A).
Regarding claims 23-25 Luksik teaches that combinations using multiple checkpoint inhibitors with or without other immune-based strategies may be the most effective means in generating the most robust antitumor immune response for glioblastoma treatment (Luksik, pg. 1061, [1]). Luksik additionally teaches that the most common sources of metastatic brain tumors are malignancies originating in the lungs, breast, and skin (malignant melanoma) (Luksik, pg. 1049, right column, [1]). Luksik further teaches that FDA approved immune checkpoint inhibitors such as ipilimumab (antibody targeting CTLA-4), pembrolizumab and nivolumab (both anti-PD-1 monoclonal antibodies) have produced profound survival benefits that are often long-lasting in responders (Luksik, pg. 1050, left column, [1]). Pembrolizumab and nivolumab are PD-1 receptor inhibitors that bind to PD-1.
It would have been obvious to one of ordinary skill in the art to combine the above teachings to include immune checkpoint inhibitors in the composition, wherein said composition induces T-Cell activity. Specifically, it would have been obvious to administer the immune checkpoint inhibitor ipilimumab or nivolumab in addition to the Desulfovibrio strains used in the combined teachings of Busi, Sears, and Lezzi. Lezzi already teaches a method of treating and preventing cancer by administering a composition comprising Desulfovibrio bacteria (Lezzi, claim 1). Lezzi further teaches that the method of treating or preventing cancer additionally involves the administration of an immune checkpoint inhibitor such as a CTLA-4 inhibitor, an inhibitor of the interaction of PD-1 with its ligand PD-L1, or more particularly a monoclonal antibody against human CTLA4, PD-1, or PD-L1 (Lezzi, claims 8, 10, 14). Furthermore, in addition to brain tumors, Sears teaches that their method may be used to treat or prevent cancers such as melanoma, lung cancer, and breast cancer (Sears, pg. 7, ln 11-19) and Busi teaches the anti-tumor capabilities of D. vulgaris (abstract). One would have been motivated to combine the above teachings, because Luksik suggests that CTLA-4 and PD-1 inhibitors may be useful in glioblastoma therapy (Luksik, pg. 1057, left column, [1]). Furthermore, a person of ordinary skill in the art would have a reasonable expectation of success because the above immune checkpoint inhibitors (nivolumab, ipilimumab) are FDA approved and have produced profound survival benefits that are often long-lasting in responders (Luksik, pg. 1050, left column, [1]). Furthermore, Lezzi teaches that nivolumab or ipilimumab may be used in combination with Desulfovibrio strains (Lezzi, claims 1, 8, 10, 11; Table 2A,; pg. 10, ln 5-8). Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
No claim is in condition for allowance
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 SYNPHANE SHELTON whose telephone number is (571)272-6318. The examiner can normally be reached 8:30am-6pm.
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, Robert Mondesi can be reached at (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. /S.L.S./Examiner, Art Unit 1652
/ROBERT B MONDESI/ Supervisory Patent Examiner, Art Unit 1652
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