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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-3, 6, 9-10, 12-14, 16-17, 75-77, 86-87, and 89-90), in the reply filed on 3/27/2026 is acknowledged.
Response to Amendment
Applicant’s amendment to the claims filed 3/27/2026 is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Claims 1-3, 6, 9-10, 12-14, 16-17, 75-77, 86-87, and 89-90 are pending and have been examined on the merits.
Priority
This application is a National-Stage entry of PCT/US2022/014420, filed 1/28/2022, which claims benefit to U.S. Provisional Patent Application No. 63/143,665, filed 1/29/2021. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/8/2023; 6/5/2025; and 4/20/2026 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to because Figures 2, 3, 4, 5, and 6 have text at too low of a resolution or clarity to have any meaningful information conveyed therein. The text reflecting the identity of the bacterial species/strains is unreadable, and therefore the data in the drawings cannot be relied upon for any argument regarding patentability. This may be due to a compression artifact, especially if the drawings had picture files that contained the text. For correction, the inclusion of written text or annotations may overcome such resolution issues.
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 Objections
Claims 1, 3, 17, 75, and 90 are objected to because of the following informalities:
For all of claims 1, 3, 17, 75, and 90, the recitation of a genus or species should always be in italics. Higher ranks like order and family are traditionally unitalicized.
Claim 1 recites a listing of numerous bacteria in (b). The bacteria listing includes various entries that are improper or confusing and thus require either correction or additional explanation. This includes:
“Species Ruminococcaceae UCG 010 unclass” (does this refer to any possible unclassified species in the genera Ruminococcaceae UCG 010?);
“Genus Lachnospiracea ge” (Lachnospiracea is a family, thus is “ge” meant to include all of the possible genera?);
“Species [Ruminococcus] torques” (why is Ruminococcus in brackets?); and
“Species [Clostridium] celerecrescens” (because of the brackets)”.
This language is also found in claims 17 and 90.
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 2-3, 12-14, 76-77, 86, and 87 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.
Claim 2 recites the limitation "claim 1(a)" in line 1. There is insufficient antecedent basis for this limitation in the claim. The term “(a)” refers to a particular condition/alternative in the method of claim 1. There is no “claim 1(a)”. The resulting dependent claim is improper because it does not refer specifically to a previous claim. Further, it is unclear if the recitation of “claim 1(a)” is meant to limit the dependent claim to only the optional condition of (a) and exclude the options of “(b)”. Because the scope of the claim cannot be determined, the claim is rejected as indefinite.
For overcoming this rejection, it is suggested to amend the language of claim 2 to “The method of claim 1, wherein the individual has cancer and wherein (a) further comprises that the response to the therapy for the individual is or has a risk of being a partial response, stable disease, or progressive disease.” or language similar thereto.
Claim 3 recites the limitation "claim 1(b)" in line 1. There is insufficient antecedent basis for this limitation in the claim. The term “(b)” refers to a particular condition/alternative in the method of claim 1. There is no “claim 1(b)”. The resulting dependent claim is improper because it does not refer specifically to a previous claim. Further, it is unclear if the recitation of “claim 1(b)” is meant to limit the dependent claim to only the optional condition of (b) and exclude the options of “(a)”. As discussed for claim 2, claim 3 is rejected as indefinite.
Claim 12 recites the limitation "1(b)" in line 1. There is insufficient antecedent basis for this limitation in the claim. As discussed for claim 2 claim 12 is rejected as indefinite. Claim 12 also recites “the step of”, which is not previously referenced. “The” should be corrected to “a”.
Claim 13 recites the limitation "1(a)" in line 1. There is insufficient antecedent basis for this limitation in the claim. As discussed for claim 2, claim 13 is rejected as indefinite.
Claim 14 recites the limitation "the dosage" in line 1. There is insufficient antecedent basis for this limitation in the claim. None of the previous claims recite dosage. Further, it is unclear if “the dosage” refers to frequency of the treatment, or amount of cells to be delivered. From the specification, and the general knowledge in the art, it is apparent that CAR-T cell doses are highly patient-specific and tailored to the individual receiving the treatment. Thus, it is unclear what the limitation “the dosage of the CAR T-cell therapy is increased” requires.
Claim 76 recites the limitation "claim 75(a)" in line 1. There is insufficient antecedent basis for this limitation in the claim. The term “(a)” refers to a particular condition/alternative in the method of claim 75. There is no “claim 75(a)”. The resulting dependent claim is improper because it does not refer specifically to a previous claim. Further, it is unclear if the recitation of “claim 75(a)” is meant to limit the dependent claim to only the optional condition of (a) and exclude the options of “(b)”. Because the scope of the claim cannot be determined, the claim is rejected as indefinite.
Claim 77 recites the limitation "claim 75(b)" in line 1. There is insufficient antecedent basis for this limitation in the claim. The term “(b)” refers to a particular condition/alternative in the method of claim 75. There is no “claim 75(b)”. The resulting dependent claim is improper because it does not refer specifically to a previous claim. Further, it is unclear if the recitation of “claim 75(b)” is meant to limit the dependent claim to only the optional condition of (b) and exclude the options of “(a)”. As discussed for claim 76, claim 77 is rejected as indefinite.
Claim 86 recites the limitation "75(a)" in line 1. There is insufficient antecedent basis for this limitation in the claim. As discussed for claim 76, claim 86 is rejected as indefinite.
Claim 87 recites the limitation "the dosage" in line 1. There is insufficient antecedent basis for this limitation in the claim. None of the previous claims recite dosage. Further, it is unclear if “the dosage” refers to frequency of the treatment, or amount of cells to be delivered. As discussed for claim 14, it is unclear what is required by the limitation “the dosage of the CAR T-cell therapy is increased”, and claim 87 is rejected as being indefinite.
Claim Rejections - 35 USC § 112(a) - Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2-3, 6, 12, 16-17, 75-77 and 89-90 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for predicting or determining a response to a CAR T-cell therapy, does not reasonably provide enablement for predicting or determining a response to any and all therapies. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to perform the invention commensurate in scope with these claims.
“The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue.” In re Angstadt, 537 F.2d 498, 504, 190 USPQ 214, 219 (CCPA 1976). Factors to be considered in determining whether undue experimentation is required are summarized in In re Wands (858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. See MPEP § 2164.01(a). The factors considered to be most relevant to the instant invention are addressed in detail below.
(A) The breadth of the claims:
Claims 1 and 75 are drawn to methods of determining or predicting a therapy response for an individual, comprising the step of analyzing a microbe composition from the gut microbiome of the individual, and comparing the microbe composition to determine the presence and/or abundance of bacteria that indicate that (a) the therapy for the individual will not be efficacious, compared to a standard or another individual, or (b) has a risk of not being efficacious, or that the therapy for the individual will be efficacious or has an increased chance of being efficacious, compared to a standard or another individual.
The dependent claims 2-3 and 76-77 further recite additional limitations regarding the individual having cancer, and the response to the therapy.
Claim 6 recites that the therapy is an immunotherapy, however the disease against which treatment is sought is not limited. Thus claim 6 is found to encompass any immunotherapy (e.g. for preventing GVHD, neurological disorders, and autoimmune disease), not just those directed to treating cancer.
The dependent claims 16-17 and 89-90 recite administering a probiotic composition or performing a fecal transplant, which conveys one or more beneficial microbes, as enumerated in claims 17 and 90.
None of these claims practically limit the type of therapy which is to be administered. Even just cancer therapies are vast and thus these claims encompass at least surgical intervention, radiation, chemotherapy, and immunotherapies.
(B) The nature of the invention:
As evidenced from the claims and from the specification of the disclosure, the nature of the invention is related to using data regarding the gut microbiota for making a determination of an outcome (or likelihood of an outcome) for an immunotherapy such as adoptive cell transfer therapy, including CAR-T therapy, for treating individuals with cancer.
(C) The state of the prior art:
The following references are discussed in order to demonstrate the knowledge and level of unpredictability in the arts of relating microbiome composition to therapy responses.
Helmink et al. (“The microbiome, cancer, and cancer therapy.” Nature medicine vol. 25,3 (2019): 377-388. doi:10.1038/s41591-019-0377-7) is a review article that teaches that certain microbes may confer susceptibility to certain cancers and may also influence response to specific therapeutics (Abstract). Helmink describes that next-generation sequencing technology is used to study tumor and host genomes as well as those of the vast array of microorganisms that exist within living organisms. Helmink states that “results from numerous studies now suggest there is a link between the commensal microbiota and cancer, including recent compelling evidence regarding the role of the gastrointestinal (gut) microbiota in modulating responses to cancer immunotherapy” (Page 377, left col and Fig. 2). Helmink also further discusses that numerous studies have focused on the role of the gut microbiota in immune checkpoint blockade therapies (see e.g. pg. 379, left col). Helmink teaches the known treatments that can positively impact the gut microbiome include Fecal microbiota transplantation (FMT) and states that “there are several current clinical trials incorporating modulation of the gut microbiota via FMT in the context of cancer therapy (Table 1)” (see page. 381-382 and Table 1). Fig. 3 of Helmink demonstrates a number of bacterial species known to be enriched in responders or nonresponders to cancer immunotherapy agents. However, it is noted that the bacterial species classified as enriched in responders or nonresponders in Fig. 3 are not consistent with the instantly claimed bacteria species. Although there is some overlap, the direction of the predictions is not necessarily the same. Helmink concludes by stating that “This field is young, and we are left with many unanswered questions—especially regarding the mechanism of action as well as the exact bacterial species or group of bacterial species that are most important in mediating antitumor effects and overall health.”. (see pg. 385, left col).
Abid et al. (“Gut microbiome and CAR-T therapy.” Experimental hematology & oncology vol. 8 31. 19 Nov. 2019, doi:10.1186/s40164-019-0155-8, on IDS filed 11/8/2023) is a review that discusses the knowledge at the time regarding therapies using chimeric antigen receptor (CAR) T-cells and possible interactions with the gut microbiome (Title, Abstract). Abid states that “the gut microbiome has emerged as one of the key host factors that could potentially be modulated to enhance responses to immunotherapy” (Abstract). Abid teaches that at the time of publication, it was unknown what gut microbiota modulates anti-tumor responses to CAR T-cells, however, the reference states that “based on molecular and immunological understanding, we hypothesize that strategically manipulating gut microbiota may enhance responses to CAR T-cells” (Abstract). In Table 1, the reference discusses known gut microbial taxa and their influence on systemic immunity and response to immunotherapy. It is evident from Abid that there is no established and predictable means for predicting the effects of cancer therapy on CAR-T response.
Van den Brink, et al. (US PGPub No. 2018/0274036, on IDS filed 11/8/2023, later issued as U.S. Pat. No. 11,597,979) discloses methods and compositions for reducing the risk of cancer relapse in a subject who has received cancer treatment (Abstract), and discusses that various gut microbiota are associated with a reduced risk of cancer relapse. Van den Brink also address the administration of beneficial probiotic bacteria in order to adjust the risk of cancer relapse or increase the chance of survival from a cancer replace, and discusses that the probiotic may comprises endogenous flora, for example, an autologous fecal microbiota transplant, that are re-introduced into the subject ([0188]). However, it is noted that the microorganisms recited in Van den Brink are notably distinct from those discussed herein. Particularly, Van den Brink teaches detecting Streptococcus anginosus and Finegoldia magna, which therein are among the bacteria associated with a reduced risk of cancer relapse (Abstract). In the instant disclosure, Streptococcus anginosus and Finegoldia magna are taught to be suggestive of a reduced response to the desired therapy. Thus, this indicates that there is little predictability in the correlation of gut microbes with the effectiveness of different treatments.
Schubert et al. (“The Potential Role of the Intestinal Micromilieu and Individual Microbes in the Immunobiology of Chimeric Antigen Receptor T-Cell Therapy.” Frontiers in immunology vol. 12 670286. 31 May. 2021, doi:10.3389/fimmu.2021.670286) discusses the principles of CD19-CART immunotherapy and major aspects of the gut microbiome and its modulators that impact antitumor T cell transfer therapies (Title, Abstract). Schubert discloses that pathogenic bacteria, including E. coli has been associated with severe infections following CAR-T infusion and that the gut as site of infection and intestinal commensals were found to account for a considerable fraction of infections (pg. 3, col 2) . Schubert also discloses a study in which Lachnospiraceae and Ruminococcaceae were associated with patients who had complete remission (see pg. 7, the paragraph spanning cols 1 and 2). Schubert states that the role of the gut microbiome in CART immunotherapy has only been marginally explored so far (Abstract).
Regarding the full scope of the claim, including the use of such predictive methods for indication of any and all treatments, Qusty et al. (“The Role of Gut Microbiota in the Efficacy and Side Effect Profile of Biologic Therapies for Autoimmune Diseases.” 2024. Cureus 16(10): e71111. doi:10.7759/cureus.71111) describes there exists a significant relationship between gut microbiota composition and the efficacy of biological therapies (Title, Abstract). Qusty et al. teaches that “specific bacterial taxa, such as Clostridiales and Roseburia inulinivorans, were associated with improved therapeutic responses, while alterations in microbiota were linked to increased adverse events” (Abstract, Table 5). Qusty discusses one study in which an increased abundance of Clostridiales is associated with a positive response to infliximab in Crohn's disease patients (pg. 7, 1st paragraph). Another study discussed therein found that higher levels of Roseburia inulinivorans and Burkholderiales species as markers for improved response to vedolizumab in ulcerative colitis and Crohn's disease subjects (pg. 7, 1st paragraph). It is noted that this review does not find any cohesive bacterial profiles among the different studies. This suggests that for each treatment and disease, the microbiome composition that results in favorable responses may be widely different.
Cho et al. (“Targeting friend and foe: Emerging therapeutics in the age of gut microbiome and disease.” Journal of microbiology (Seoul, Korea) vol. 56,3 (2018): 183-188. doi:10.1007/s12275-018-8037-z) reviews the development of innovative therapeutics that target the microbiome to treat disease, and highlight key findings in the interplay between host microbes and therapy (Abstract). Cho states that “the difficultly of precisely defining taxonomy of a complex and dynamic microbial population makes it especially challenging to use standard drug development approaches of one target, one drug to utilize the microbiome to treat disease.” (pg. 184, left col, top paragraph). Fig. 1 of Cho describes approaches to microbial transplant therapies, and discusses the analysis of diseased versus healthy microbial populations by metagenomics, metabolomics, or other techniques to uncover key commensal microbial factors that influence disease pathology, gut homeostasis, and immune response (see pg. 185). Cho discusses studies that found that Bifidobacterium longum, Collinsella aerofaciens, and Enterococcus faecium were present in significantly higher amounts in patients who responded to immunotherapy when compared to non-responders (pg. 185, left col, under section “FMT and cancer treatment”). While other studies found A. muciniphila or members of the Ruminococcaceae family were higher in responding patients (pg. 185). It is evident from all of Cho that different diseases are related to distinct microbiome changes, and that predicting a therapy response depends on the disease state and the therapy type.
Since the knowledge of linking gut microbiome composition with any treatment and any disease remains largely unsolved, means for performing the prediction as claimed for any therapy is highly unpredictable.
(D) The relative skill of those in the art:
The relative skill of those in the art is high, and would include medical practitioners and scientists having many years of training and experience. However, such artisans would recognize the vast diversity of treatments encompassed by the instant claims, and would understand that the diseases against which treatment is sought can be highly different. Further, one having high skill in the art of microbiome studies would recognize that a desirable microbiome for one type of treatment may be completely different for treatment of a completely different disease.
(E) The predictability or unpredictability of the art:
It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved”. MPEP§ 2164.03 states that “[i]n cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). This is because in art areas having a high degree of uncertainty (i.e. the unpredictable arts) it is not reasonably predictable from the disclosure of one species, what other species will work”.
The biological arts are often unpredictable, often requiring each embodiment or species of a treatment or a cellular composition to be individually assessed for the desired treatment effectiveness. Further, based on the cited art above, there is much to be discovered regarding the effects of certain gut microbiota species on treatment responses. There would have been very little predictability in using the claimed prediction method for any possible therapy, even when limited to only cancer therapies.
(F) The amount of direction or guidance presented
The specification has only provided embodiments and examples regarding the use of the claimed invention in predicting the response of adoptive cell therapies for treating cancer. “In this disclosure, it is shown that gut microbiota diversity and particular gut microbiome compositions for an individual correlate with efficacy and toxicities associated with CAR-T therapy (as an example of adoptive cell therapy) for a cancer” (in [0060] of the specification).
However, the specification does not provide support for performing the claimed method with any and every therapy, or any immunotherapy. No other therapies or diseases (other than cancer) are significantly discussed nor envisioned herein. Therefore, there is no guidance for using this predictive method for predicting the response of any therapy, other than for the enabled subject matter of adoptive cell therapy including CAR-T therapy, as identified above.
(G) The existence of working examples:
There is only one Example provided in the instant specification (Example 1, on pages 60-62). In this working example, stool samples were collected from patients undergoing treatment with anti-CD19 CAR-T therapy ([0292]). The analysis of the gut microbiome was performed, and correlations were determined among the abundance of certain bacterial species with CR, PR, SD, or PD (see [0293]-[0297]). However, no other working examples are provided. There is no examples of any other therapies, nor any other diseases being tested. Thus, the working examples are found to only demonstrate using the microbiome analysis for predicting a response to a CAR-T cell therapy in cancer patients.
(H) The quantity of experimentation necessary:
Considering the state of the art as discussed by the references above, and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to use the claimed predictive method for determining a response to any possible therapy or any immunotherapy, and these claims are not limited to only cancer immunotherapies. It is also apparent from the art that for any given disease and treatment, extensive studies must be performed to determine useful microbiota indicators of a therapy’s effectiveness. There is no evidence in the instant disclosure, or from general knowledge in the art, that the instant claimed prediction method is applicable to any and all therapies, beyond the CAR-T therapies demonstrated herein.
When weighing all of the factors described above, it is herein determined that the results of the method as claimed would be highly unpredictable to one skilled in the art at the time of the invention when considering the full scope of the claimed therapies.
Thus, is the Examiner’s position that claims 1, 2-3, 6, 12, 16-17, 75-77 and 89-90 are drawn to subject matter which is not described in the specification in such a way to enable one skilled in the art to perform the entire scope of the claimed invention without undue experimentation.
Claims 13-14 and 86-87 limit the therapy to adoptive cell transfer therapies including CAR-T cell based therapies. Thus, these claims are considered sufficiently enabled.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3, 6, 9-10, 12-14, 16-17, 75-77, 86-87, and 89-90 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
For determining subject matter eligibility, the following analysis was considered, per MPEP § 2106.
Patent Eligibility Analysis Step 1: Step 1 of the eligibility analysis asks: is the claim to a process, machine, manufacture or composition of matter? Yes, the claims are directed to a method. (Claims 1-3, 6, 9-10, 12-14, 16-17, 75-77, 86-87, and 89-90, STEP 1: YES).
Patent Eligibility Analysis Step 2A Prong 1: Step 2A, prong 1 asks: does the claim recite an abstract idea, law of nature, or a natural phenomenon (product of nature)?
Claims recite 1 and 75 both recite “a method of determining or predicting a therapy response for an individual, comprising the step of analyzing a microbe composition from the gut microbiome of the individual”. The dependent claims also require the “step of analyzing a microbe composition” and do not further define or limit “analyzing”.
Thus, the claimed method amounts to mental processes involving concepts performed in the human mind, including an observation, evaluation, judgment, or opinion (see MPEP § 2106.04(a)(2), subsection III, which describes the analogous situation of “collecting and comparing known information (claim 1), which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1067, 100 USPQ2d 1492, 1500 (Fed. Cir. 2011), found by the court to recite mental a process).
Thus, all of the claims recite an abstract idea in the determining or predicting a therapy response for an individual including the step of analyzing a microbe composition. (Claims 1-3, 6, 9-10, 12-14, 16-17, 75-77, 86-87, and 89-90, Step 2A, Prong 1: YES).
Patent Eligibility Analysis Step 2A Prong 2: Step 2A, prong 2 asks: does the claim recite additional elements that integrate the judicial exception into a practical application?
Claims 1 and 75 do not recite any additional elements besides the abstract idea and the method of “analyzing” the gut microbiome, then sets forth groups of bacteria that are found to be indicative of (a) that a therapy for the individual will not be efficacious or has a risk of not being efficacious if they are present, or (b) the therapy for the individual will be efficacious or has an increased chance of being efficacious, compared to a standard or another individual.
However, the recitation of these particular bacteria (while the bacteria themselves and the presence or absence of them in a subject are all natural phenomenon) does not amount to more than determining a correlation, performing mental comparisons, and making a decision.
The recitation of analyzing, at such a high level of generality, the gut microbiome and thus determining or predicting a therapy based on the presence or absence of certain microbes does not result in a practical application or implementation of the mental activity.
Therefore, these additional elements do not add more than insignificant extra-solution activity to the judicial exception. The collection of data about the gut microbiome amounts to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). MPEP § 2106.05(g) describes that mere data gathering includes “Determining the level of a biomarker in blood, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968. See also PerkinElmer, Inc. v. Intema Ltd., 496 Fed. App'x 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir. 2012) (assessing or measuring data derived from an ultrasound scan, to be used in a diagnosis)”, and “Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989)”, which are analogous to the instantly claimed analysis of the gut microbiome.
Claims 2-3 and 76-77 limit the individual to one having cancer, predicting what the degree of the response to the therapy might be, or that the gut microbiome has Flavonifractor plautii. This does not implement the ineligible mental activity into a practical application.
Claims 6 recites that the therapy comprises immunotherapy, but as described above, this does not implement the abstract idea into a practical application.
Claim 9 recites that the therapy comprises adoptive cell therapy and the cells of the adoptive cell therapy are modified to comprise one or more engineered antigen receptors. However, the modifying is recited generally and does not require or recite the use of any information from the abstract idea, the analyzing step.
Claim 10 recites that the engineered antigen receptor comprises one or more chimeric antigen receptors (CAR) or non-native T-cell receptors, which does not practically implement the abstract idea.
Claim 12 recites a step of administering a therapeutically effective amount of the therapy to the individual. However, this is a generic step of “administering” and is not limited by any determinization or implementation of the abstract idea. Because the claimed administering is not practically affected by the determining or predicting steps, this amounts to a general step, and does not implement the abstract idea into a specific application.
In regards to claims 6, 9-10, and 12, MPEP § 2106.04(d)(2) describes that in order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. In the instant case, the therapy appears to be administered regardless of any other information, obtained by the ineligible abstract idea.
Claims 13 and 86 recites that the therapy is CAR T-cell therapy and the CAR T-cell therapy is modified prior to administering to the individual to enhance efficacy of the CAR T- cell therapy, while claims 14 and 87 recites the dosage of the CAR T-cell therapy is increased. However, as described for claim 12, the claimed modification and increase of the dosage is not practically affected by the abstract ideas of determining or predicting. Thus, these amount to general treatment steps, and does not implement the abstract idea into a specific application.
MPEP § 2106.04(d)(2) states that: “The treatment or prophylaxis limitation must impose meaningful limits on the judicial exception, and cannot be extra-solution activity or a field-of-use.” In the instant case, although these dependent claims recite that the treatment is “modified” or “increased”, there is no positive limitations linking the mental activity to the modification.
Regarding claims 16-17 and 89-90, the administration of an effective amount of one or more probiotics and/or one or more fecal transplants, does not require any particular information or data obtained from performing the abstract idea. Instead these amount to merely general administration steps of purely natural products that are found in gut microbiomes. There is no specific recitation to affirmatively apply data obtained from the ineligible mental activity.
Therefore, the judicial exception is not integrated into a practical application because the claims do not recite additional elements that implement the mental processes into a particular application (Claims 1-3, 6, 9-10, 12-14, 16-17, 75-77, 86-87, and 89-90, Step 2A, Prong 2: NO).
Patent Eligibility Analysis Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
MPEP § 2106.05 recites that “an inventive concept "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself." Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016)” In the instant case, the ineligible mental processes of determining and predicting the response to a therapy, based upon the presence or lack of identified microorganisms, cannot be used as convincing evidence of the claims amount to significantly more than the judicial exception due to incorporation of an inventive concept.
None of the additional elements recited in claims 1-3, 6, 9-10, 12-14, 16-17, 75-77, 86-87, and 89-90 amount to significantly more than the ineligible natural product. The additional elements amount to extra-solution activity or general instructions for a field-of-use.
Regarding these additional elements, particularly the step of analyzing a microbe composition from the gut microbiome of the individual, this clearly amounts to well-understood, routine, conventional activities previously known to the industry.
MPEP § 2106.05(d) describes that the courts have recognized several laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity, including “ii. Using polymerase chain reaction to amplify and detect DNA, Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015); and iii. iii. Detecting DNA or enzymes in a sample, Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at 1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088 (Fed. Cir. 2017). In the instant case the collection of gut microbiome and the identification of specific species and strains through the use of PCR and DNA sequencing is analogous to these identified activities.
Further, the sequencing of microbiomes and the determination of a microbiome composition, even amount cancer patients, is considered to be well-understood, routine, and conventional, as evidenced by at least the following references:
Helmink et al. (“The microbiome, cancer, and cancer therapy.” Nature medicine vol. 25,3 (2019): 377-388. doi:10.1038/s41591-019-0377-7) is a review article that teaches that certain microbes may confer susceptibility to certain cancers and may also influence response to therapeutics (Abstract). Helmink describes that next-generation sequencing technology is used to study tumor and host genomes as well as those of the vast array of microorganisms that exist within living organisms. Helmink also states that “results from numerous studies now suggest there is a link between the commensal microbiota and cancer, including recent compelling evidence regarding the role of the gastrointestinal (gut) microbiota in modulating responses to cancer immunotherapy” (Page 377, left col and Fig. 2). Helmink also further discusses that numerous studies have focused on the role of the gut microbiota in immune checkpoint blockade therapies (see e.g. pg. 379, left col). Helmink teaches the known treatments that can positively impact the gut microbiome include Fecal microbiota transplantation (FMT) and states that “there are several current clinical trials incorporating modulation of the gut microbiota via FMT in the context of cancer therapy (Table 1)” (see page. 381-382 and Table 1). Figure 3 of Helmink demonstrates a number of bacterial species known to be enriched in responders or nonresponders to cancer immunotherapy agents.
Rotz and Dandoy. (“The microbiome in pediatric oncology.” Cancer vol. 126,16 (2020): 3629-3637. doi:10.1002/cncr.33030) review the knowledge regarding the influence of the human microbiome in pediatric hematology and oncology (Title, Abstract). Rotz and Dandoy discusses that advances in next-generation sequencing have allowed for the timely detection of microbial composition and function and that details regarding species, subspecies, or the presence of specific genes (e.g. antibiotic resistance) can be obtained via metagenomic shotgun sequencing (see pg. 3629, middle paragraph). Rotz and Dandoy also discusses that the microbiome is considered to modulate response to immunotherapies (see e.g. page 3630 and Table 2).
Abid et al. (“Gut microbiome and CAR-T therapy.” Experimental hematology & oncology vol. 8 31. 19 Nov. 2019, doi:10.1186/s40164-019-0155-8, on IDS filed 11/8/2023) is a review that discusses the knowledge at the time regarding therapies using chimeric antigen receptor (CAR) T-cells and possible interactions with the gut microbiome (Title, Abstract). Abid states that “the gut microbiome has emerged as one of the key host factors that could potentially be modulated to enhance responses to immunotherapy” (Abstract). Abid teaches that at the time of publication, it was unknown what gut microbiota modulates anti-tumor responses to CAR T-cells, however, the reference states that “based on molecular and immunological understanding, we hypothesize that strategically manipulating gut microbiota may enhance responses to CAR T-cells” (Abstract). In Table 1, the reference discusses known gut microbial taxa and their influence on systemic immunity and response to immunotherapy.
Van den Brink, et al. (US PGPub No. 2018/0274036, on IDS filed 11/8/2023, later issued as U.S. Pat. No. 11,597,979) discloses methods and compositions for reducing the risk of cancer relapse in a subject who has received cancer treatment (Abstract), and discusses that various gut microbiota are associated with a reduced risk of cancer relapse. Van den Brink teaches that microbiome abundance or amount of bacteria present in a sample can be determined by shotgun sequencing of bacterial DNA, PCR amplification of specific genes carried by the bacteria, including the sequence of 16S rRNA ([0132]-[0133]). This reference also discusses that such analysis was already known to the art (see e.g. [0205]: “16S rRNA deep-sequencing as previously described”). Van den Brink also address the administration of beneficial probiotic bacteria in order to adjust the risk of cancer relapse or increase the chance of survival from a cancer replace, and discusses that the probiotic may comprises endogenous flora, for example, an autologous fecal microbiota transplant, that are re-introduced into the subject ([0188]). This disclosure also discusses the application of known cancer therapies including radiation therapy, chemotherapy, immunotherapy (for example, but not limited to, antibodies directed to CTLA-4, PD-1, CD52, and/or CD20; and cytokines such as interferons and interleukins), stem cell therapy and/or cellular therapies (for example, but not limited to, CAR-modified T cells and other antigen-specific T cells) ([0193]).
Regarding the adjustments of dosages or modification of treatments, at least generally, Van den Brink also states that “As is well known in the medical arts, dosages for any one patient depends upon many factors, including stage of the disease or condition, the severity of the disease or condition, the patient's size, body surface area, age, the particular compound to be administered, sex, time and route of administration, general health, and interaction with other drugs being concurrently administered.” ([0179]).
Thus, the idea to generally link analyzing gut microbiomes in cancer immunotherapy patients with the prediction of therapy results cannot be considered an inventive concept that amounts to significantly more than the ineligible mental process.
Further, the modification of therapies, as in the dependent claims, cannot be considered to amount to significantly more than the abstract idea as these are high-level general recitations that do not particularly recite the application of data or instruction from the analysis steps.
When considered individual or in combination, the claims do not amount to more than the judicial exception. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception (Claims 1-3, 6, 9-10, 12-14, 16-17, 75-77, 86-87, and 89-90, Step 2B: NO).
As such, the claims do not qualify as eligible subject matter. For these reasons the claims are rejected under section 101 as being directed to non-statutory subject matter.
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, 6, 9-10, 12, 16-17, 75-77, and 89-90 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Wargo et al. (WO 2020106983, on IDS filed 6/5/2025).
“Wargo” pertains to methods and compositions for treating cancer and for predicting a subjects' response to combination checkpoint inhibitor therapy (Title, Abstract). Wargo states that the method further comprises treating the subject with a combination of (i) a PD-1, PDL1, or PDL2 inhibitor and (ii) a CTLA-4, B7-1, or B7-2 inhibitor (Abstract).
Wargo discloses a method for determining or predicting a cancer immunotherapy response for an individual, comprising a step of analyzing a microbe composition from the gut microbiome of the individual (see [0008]: “the disclosure relates to methods of treating cancer and/or reducing toxicity to a therapy in a subject comprising administering to a subject determined to have a favorable microbial profile in the gut microbiome a combination of (i) a PD-1, PDL1, or PDL2 inhibitor and (ii) a CTLA-4, B7-1, or B7-2 inhibitor.”; and [0032]-[0033]: “the subject was or is determined to comprise an unfavorable microbial profile by analyzing the microbiome in a sample from the subject. In some embodiments, the sample is a fecal sample or buccal sample. In some embodiments, the analyzing comprises performing 16S ribosomal sequencing and/or metagenomics whole genome sequencing.”).
The gut microbiome profile discussed in Wargo that is associated with an unfavorable microbial profile (see e.g. [0030]) includes, inter alia, bacteria belonging to the genus Bacilli, which anticipates the limitation of “the Order Bacillales” which is recited as one of the alternatives in the instant claims condition (a).
The gut microbiome profile discussed in Wargo that is associated with an favorable microbial profile (see e.g. all of [0040]) includes, inter alia, Butyricicoccus pullicaecorum, bacteria of the genus Prevotella, the genus Eisenbergiella including Eisenbergiella massiliensis, the genus Ruminococcaceae, those of the genus Barnesiella including Barnesiella intestinihominis, Clostridium celerecrescens, the genus Fournierella, the genus Porphyromonas, the genus Lachnoclostridium, the genus Intestinimonas, Anaerotignum lactatifermentans, the genus Flavonifractor including Flavonifractor plautii (see e.g. [0040]).
Regarding claim 75, which recites essentially the same methods as claim 1, but has different bacteria profiles, Wargo also discloses that the favorable bacteria profile comprises Odoribacter splanchnicus (see [0040]), as recited in (b) of claim 75.
Thus, Wargo is deemed to anticipate the methods of claims 1 and 75 because the reference discloses determining or predicting if a cancer therapy for an individual in need thereof will not be efficacious or has an increased chance of being efficacious and recites multiple of the instantly claimed alternatives. It is noted that the instant claims are recited fully in the alternative, and only require that at least one of the conditions is met, having, under the B.R.I., a gut microbiome comprising at least one of the enumerated microbes.
Regarding claims 2-3 and claims 76-77, Wargo discloses that a responsive patient may be one identified as having a complete response (CR), which is disappearance of all target lesions or a partial response (PR), or could identified as having stable disease (SD) or progressive disease (PD) (see [0104] and [0250]).
Regarding claim 6, Wargo discloses that the methods can be used in conjunction with cancer immunotherapies ([0008]: “the disclosure relates to methods of treating cancer and/or reducing toxicity to a therapy in a subject comprising administering to a subject determined to have a favorable microbial profile in the gut microbiome a combination of (i) a PD-1, PDL1, or PDL2 inhibitor and (ii) a CTLA-4, B7-1, or B7-2 inhibitor.”; and [0154]-[0155]).
Regarding claims 9 and 10, Wargo discloses that cancer therapies employed with the methods therein include CAR-T cell therapies, which requires the use of T-cells modified with engineered chimeric antigen receptors ([0160]-[0163]). Wargo also discloses that the therapies may include “Adoptive T cell therapy” (see [0167]-[0168]).
Regarding claim 12, Wargo discloses that a therapeutically effective or sufficient amount of an immune checkpoint inhibitor, such as an antibody and/or microbial modulator, is administered to the subject ([0198]-[0200]).
Regarding claims 16-17 and 89-90, Wargo discloses administering a probiotic and/or fecal transplant to a patient ([0054]: “In some embodiments, the method further comprises treating the subject predicted to have a toxic and/or non-effective response with a composition of the disclosure.”, [0058]: “In some embodiments, the composition is a live bacterial product or a live biotherapeutic product... the composition is formulated for oral delivery... In some embodiments, the composition is formulated for administration rectally”).
The compositions of the probiotic in Wargo include, inter alia, Butyricicoccus pullicaecorum, bacteria of the genus Prevotella, the genus Eisenbergiella including Eisenbergiella massiliensis, the genus Ruminococcaceae, those of the genus Barnesiella including Barnesiella intestinihominis, Clostridium celerecrescens, the genus Fournierella, the genus Porphyromonas, the genus Lachnoclostridium, the genus Intestinimonas, Anaerotignum lactatifermentans, the genus Flavonifractor including Flavonifractor plautii, and Odoribacter splanchnicus ([0022]). Thus, the administration of a composition having at least one of these, as in claims 17 and 90, is considered anticipated by the disclosure of Wargo.
Claims 1-3, 6, 9-10, 12, 16-17, 75-77, and 89-90 are therefore rejected as being anticipated by the disclosure of Wargo.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 6, 9-10, 12-14, 16-17, 75-77, 86-87, and 89-90 are rejected under 35 U.S.C. 103 as being unpatentable over Wargo et al. (WO 2020106983).
The teachings of Wargo include all of those discussed above in the rejections under 35 U.S.C. § 102. Wargo pertains to pertains to methods and compositions for treating cancer and for predicting a subjects' response to combination checkpoint inhibitor therapy (Title, Abstract).
Wargo teaches all of the limitations of claims 1-3, 6, 9-10, 12, 16-17, 75-77, and 89-90, as discussed in detail above. It is noted that the instant claims are recited fully in the alternative, and only require that at least one of the conditions is met, having, under the B.R.I., a gut microbiome comprising at least one of the enumerated microbes.
Wargo teaches determining or predicting if a cancer therapy for an individual in need thereof will not be efficacious or has an increased chance of being efficacious and recites multiple of the instantly claimed alternatives (see [0030]-[0033] and [0040]).
However, Wargo does not explicitly teach that the therapy is a CAR T-cell therapy which is modified prior to administering to the individual to enhance efficacy of the CAR T-cell therapy, nor that the dosage of the CAR-T therapy is increased, as in claims 13-14 and 86-87.
Regarding CAR-T, Wargo teaches that cancer therapies to be employed with the methods therein include CAR-T cell based therapies, which requires the use of T-cells modified with engineered chimeric antigen receptors ([0160]-[0163]). Wargo teaches that the general premise of CAR-T therapy is to artificially generate T-cells targeted to markers found on cancer cells, and that it is known to the art to remove T-cells from a person, genetically alter them, and put them back into the patient for them to attack the cancer cells ([0162]). Further, Wargo states that “CAR-T cells create a link between an extracellular ligand recognition domain to an intracellular signaling molecule which in turn activates T cells.” ([0162]).
Regarding the selection of dosages for any treatment, Wargo teaches that the term “dosage” refers to physically discrete units suitable for use in a subject, each unit containing a predetermined quantity of the therapeutic composition calculated to produce the desired responses discussed herein in association with its administration, i.e., the appropriate route and treatment regimen and teaches that the practitioner responsible for administration will, in any event, determine the concentration of active ingredient(s) in a composition and appropriate dose(s) for the individual subject ([0094]). Further, Wargo teaches that an appropriate dosage of an immune checkpoint inhibitor and/or a microbial modulator may be determined based on the type of disease to be treated, severity and course of the disease, the clinical condition of the individual, the individual's clinical history and response to the treatment, and the discretion of the attending physician ([0190]).
Wargo also teaches that the affected treatment methods may involve the determination, administration, or selection of an appropriate cancer management regimen and predicting the outcome of the same. Wargo also states that management regimen refers to a management plan that specifies the type of examination, screening, diagnosis, surveillance, care, and treatment (such as dosage, schedule and/or duration of a treatment) provided to a subject in need thereof (e.g., a subject diagnosed with cancer) (see [0210]).
Therefore, to one having ordinary skill in the art, before the effective filing date of the instant invention, it would have been prima facie obvious in view of all of the teachings of Wargo to modify a treatment plan for a patient in need thereof, based upon one or more of the microbiome analysis and predictions taught in Wargo, wherein the modification includes adjustments in dosage of a CAR-T cell therapy.
Wargo establishes that analyzing a gut microbiome can be used to predict a patients response to a cancer immunotherapy including CAR-T cell based therapy, which is well known in the art. Wargo also discusses that the optimization and selection of appropriate dosage of cancer treatments is known and routine in the medical arts. In view of these teachings, one having ordinary skill in the art would have been motivated by the teachings of Wargo and the general knowledge in the art to modify a CAR-T cell therapy, including the increasing of dosages, based upon the predictions obtained from the presence and/or abundance of particular bacteria the gut microbiome of the subject.
MPEP § 2144.05 describes that the determination of suitable or effective concentration of a known composition or performing a known method can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
From the teachings of Wargo, it is apparent that there would have been a reasonable expectation of success modifying the teachings therein to arrive at the claimed invention because the reference discusses that CAR-T is well known in the art, that it is routine to optimize dosages and therapies, and the reference teaches at least some of the instantly recited bacteria as being indicative of a response or non-response to a cancer therapy. It is noted that the claims remain drawn to a method for predicting or determining the response to a therapy, and thus do not explicitly recite a particular treatment of the cancer.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date, as evidenced by the cited references, especially in the absence of evidence to the contrary.
Citation of Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Smith et al. (WO 2020077341, on IDS filed 11/8/2023) pertains to compositions, methods, and kits for predicting a subject's response to a CAR-T cell therapy, by analyzing the intestinal microbiome of the subject (Abstract). Smith teaches detecting patients at risk for a poor response to CAR-T cell therapy by measuring the level of the presently disclosed bacteria or bacterial genes in the microflora or microbiome of a patient receiving or considered for CAR T cell therapy, and discloses that bacteria which are detected include, inter alia, bacteria of the Ruminococcaceae family (Abstract, claims 10, 11, 51 and 52).
Culler et al. (US PGPub No. 20220378855, claiming benefit to PCT/US2020/065693, filed Dec. 17, 2020) pertains to modulating or modifying an individual's gut microbial population using compositions such that the pharmacodynamics of a drug administered to the individual is altered, thereby controlling, ameliorating, preventing and/or treating of cancer (Title, Abstract). Culler discusses that biomarkers in the form of microbial species abundance in the gut may be indicative of patient response or non-response to a composition or method as provided herein, including e.g., a chemotherapy, a radiation therapy, an immune checkpoint inhibitor (e.g., a checkpoint inhibitor therapy), a Chimeric Antigen Receptor (CAR) T-cell therapy (CAR-T) or other immunotherapy or cancer treatment ([0155], [0360]).
Conclusion
No claims are allowable.
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/A.T.M./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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