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 .
The response filed on May 01, 2026 is received.
Claims 1-20 are pending in this application, claims 11 and 12 are withdrawn from further consideration (See Restriction/Election below), and claims 1-10 and 13-20 are being examined.
Restriction/Election:
Applicant's election with traverse of Group I, claims 1-10 and 13-20, in the reply filed on 05/01/2026, is acknowledged.
The traversal is on the ground(s) that “ …the Examiner has not provided any indication that the content of the claims interpreted in light of the description was considered in making the assertion of a lack of unity and therefore has not met the burden necessary to support the assertion” and “In addition, MPEP § 806.03 states: [w]here the claims of an application define the same essential characteristics of a single disclosed embodiment of an invention, restriction there between should never be required. This is because the claims are not directed to distinct inventions; rather they are different definitions of the same disclosed subject matter, varying in breadth or scope of definition”.
This is not found persuasive because as indicated in the office action mailed on 03/10/2026, “Groups I and II lack unity of invention because the special technical feature of the method of claim 1 is not a special technical feature as it does not make a contribution over the prior art in view of Agnello et al. (which is also cited in IDS filed on 05/02/2024) teachings of measuring Anaerostipes hadrus in a sample collected from a subject (see for example, page 2, left column, lines 7-11, page 2, left column, line 52, page 2, right column, line 21, fig. 2, fig. 3, page 10, left column, lines 10-13, page 10, left column, line 21 to right column, line 11).”
In addition Groups I and II lack unity of invention because the special technical feature of the method of claim 1 is not a special technical feature as it does not make a contribution over the prior art in view of Sato et al. (See below 102 rejection for details).
Moreover, unity of invention determination is applied in the restriction of the instant application and not distinctness.
The requirement is still deemed proper and is therefore made FINAL
Claims 11 and 12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions (Groups II and III), there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on 05/01/2026
Objection(s):
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (See for example, paragraphs [0005} and [0051]). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112
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 7, 8, 19 and 20 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.
In claim 7, the phrase “reference value” is indefinite because the reference value is not defined. As such, the metes and bounds of the claim is not clearly set forth.
Suggestion to obviated rejection: define the reference value.
In claim 8, the phrase “reference value” is indefinite because the reference value is not defined. As such, the metes and bounds of the claim is not clearly set forth.
Suggestion to obviated rejection: define the reference value.
In claim 19, the phrase “reference value” is indefinite because the reference value is not defined. As such, the metes and bounds of the claim is not clearly set forth.
Suggestion to obviated rejection: define the reference value.
In claim 20, the phrase “reference value” is indefinite because the reference value is not defined. As such, the metes and bounds of the claim is not clearly set forth.
Suggestion to obviated rejection: define the reference value.
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.
Claim 1-10 and 13-20 are rejected under 35 U.S.C. 101 because:
The claimed invention is directed to a judicial exception, i.e., as abstract idea, without significantly more.
According to Section I of the 2019 Revised Patent Subject Matter Eligibility Guidance, “the judicial exceptions are for subject matter that has been identified as the ‘‘basic tools of scientific and technological work,’’ which includes ‘‘abstract ideas’’ such as mathematical concepts, certain methods of organizing human activity, and mental processes; as well as laws of nature and natural phenomena”, and “the USPTO has set forth a revised procedure, rooted in Supreme Court caselaw, to determine whether a claim is ‘‘directed to’’ a judicial exception under the first step of the Alice/Mayo test (USPTO Step 2A).” (Also see “2019 Revised Patent Subject Matter Eligibility Guidance, Federal Register / Vol. 84, No. 4 / Monday, January 7, 2019 / Notices, p. 50-57”).
Therefore, if the claim does recite a judicial exception (a law of nature, natural phenomenon, or subject matter within the enumerated groupings of abstract ideas in Section I), then the claim is NOT eligible at Prong One of revised Step 2A.
Claim 1 reads:
Claim 1. A method for determining a risk of an adverse event during multimodal treatment, comprising; measuring Anaerostipes hadrus in a sample collected from a subject.
And further claims 7-10 and 18-19 read:
Claim 7. The method according to claim 1, further comprising: comparing a number of bacteria of Anaerostipes hadrus in the sample with a reference value; and determining that the risk of an adverse event during the multimodal treatment is high when the number of bacteria is equal to or less than the reference value.
Claim 8. The method according to claim 1, further comprising: comparing an occupancy rate of Anaerostipes hadrus in total bacteria in the sample with a reference value; and determining that the risk of an adverse event during the multimodal treatment is high when the occupancy rate is equal to or less than the reference value.
Claim 9. The method according to claim 1, further comprising: determining that a risk of febrile neutropenia during the multimodal treatment is high when a number of bacteria of Anaerostipes hadrus in the sample is 107-7 or less per gram of the sample or an occupancy rate of Anaerostipes hadrus in total bacteria in the sample is 0.25% or less.
Claim 10. The method according to claim 1, further comprising: determining that a risk of diarrhea during the multimodal treatment is high when [[the]] a number of bacteria of Anaerostipes hadrus in the sample is 107.6 or less per gram of the sample or an occupancy rate of Anaerostipes hadrus in total bacteria in the sample is 0.084% or less.
Claim 19. The method according to claim 2, further comprising: comparing a number of bacteria of Anaerostipes hadrus in the sample with a reference value; and determining that the risk of an adverse event during the multimodal treatment is high when the number of bacteria is equal to or less than the reference value.
Claim 20. The method according to claim 2, further comprising: comparing an occupancy rate of Anaerostipes hadrus in total bacteria in the sample with a reference value; and determining that the risk of an adverse event during the multimodal treatment is high when the occupancy rate is equal to or less than the reference value.
In this case, the recited limitations “measuring Anaerostipes hadrus in a sample collected from a subject”, “comparing a number of bacteria of Anaerostipes hadrus in the sample with a reference value “, and “and determining that the risk of an adverse event …“ under the broadest reasonable interpretation, covers mental processes, for example, performing the measurement in human mind (quantifying and evaluation of data, a chart or a graph, etc.).
In addition, there are no additional element(s) recited in claim 1-10 and 13-20 that precludes the step from practically being performed in the mind.
According to the above-mentioned Guidance in Prong Two, examiners evaluate whether the claim recites additional elements that integrate the exception into a practical application of that exception. This prong adds a more detailed eligibility analysis to step one of the Alice/Mayo test (USPTO Step 2A) than was required under prior guidance.
Because there are not any additional elements recited in the claim beyond the judicial exception, the claimed method as recited in claims ?? do not integrate the judicial exception into a practical application, because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Therefore, the claimed method is not directed to patent eligible 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.
Claims 1 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sato et al. (FEMS Microbiol Ecol. 2017 Jan;93(1), p. 1-10)
Claim Interpretation:
In claim 1 the recitation “for determining a risk of an adverse event during multimodal treatment” is not given patentable weight because it occurs in the preamble and further because the body of the claim describes a complete process step.
Regarding claim 1, Sato et al. disclose a method for determining a risk of an adverse event during multimodal treatment, comprising; measuring Anaerostipes hadrus in a sample collected from a subject (number of Anaerostipes bacteria including Anaerostipes hadrus and changes in bacteria community in fecal cultures, and distribution levels, etc.) (See for example, p. 4 left-hand column last paragraph, p. 5 right-hand column last paragraph, and p. 9 left-hand column 2nd paragraph).
Regarding claim 6, Sato et al. disclose the sample is a fecal sample of the subject (fecal samples collected feces from male donors) (See for example, p. 2 right-hand column paragraph title: “Fecal samples and cultures”).
Sato et al. therefore anticipate the claimed method for determining a risk of an adverse event during multimodal treatment.
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.
Claims 1-8 and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sato et al. in view of Riviere et al. (Front. Microbiol. 2016, Vol. 7, Article 979, p. 1-21) and Syrop, J. (AJMC Article, 2016, 1 page of PDF) and Wood et al. (Appl Environ Microbiol, 1998, Vol. 64, No. 10, p. 3686-3689).
Regarding claim 1, Sato et al. teach a method for determining a risk of an adverse event during multimodal treatment, comprising; measuring Anaerostipes hadrus in a sample collected from a subject (number of Anaerostipes bacteria including Anaerostipes hadrus and changes in bacteria community in fecal cultures, and distribution levels, etc.) (See for example, p. 4 left-hand column last paragraph, p. 5 right-hand column last paragraph, and p. 9 left-hand column 2nd paragraph).
Regarding claims 6 and 18, Sato et al. teach the sample is a fecal sample of the subject (fecal samples collected feces from male donors) (See for example, p. 2 right-hand column paragraph title: “Fecal samples and cultures”).
Sato do not teach the risk of an adverse event is a risk of onset or exacerbation of an adverse event (claim 2), the multimodal treatment is a drug therapy, a surgical therapy, radiation treatment, and a combination thereof (claim 3), the multimodal treatment is a drug therapy (claim 4), the adverse event is at least one of febrile neutropenia and diarrhea (claim 5), the method further comprising comparing a number of bacteria of Anaerostipes hadrus in the sample with a reference value; and determining that the risk of an adverse event during the multimodal treatment is high when the number of bacteria is equal to or less than the reference value (claim 7), the method further comprising: comparing an occupancy rate of Anaerostipes hadrus in total bacteria in the sample with a reference value; and determining that the risk of an adverse event during the multimodal treatment is high when the occupancy rate is equal to or less than the reference value (claim 8), the adverse event is febrile neutropenia (claim 13), the adverse event is diarrhea (claim 14), the multimodal treatment is a drug therapy, a surgical therapy, radiation treatment, and a combination thereof (claim 15), the multimodal treatment is a drug therapy (claim 16), the adverse event is at least one of febrile neutropenia and diarrhea (claim 17), the method further comprising: comparing a number of bacteria of Anaerostipes hadrus in the sample with a reference value; and determining that the risk of an adverse event during the multimodal treatment is high when the number of bacteria is equal to or less than the reference value (claim 19), the method further comprising: comparing an occupancy rate of Anaerostipes hadrus in total bacteria in the sample with a reference value; and determining that the risk of an adverse event during the multimodal treatment is high when the occupancy rate is equal to or less than the reference value (claim 20).
However, regarding claims, 2-5 and 13-18, Riviere et al. teach Anaerostipes hadrus is among the important butyrate-producing bacteria species in human (Anaerostipes spp. including Anaerostipes hadrus is among important butyrate-producing bacteria species in human colon) (See for example, p. 6 left-hand column 2nd paragraph), and cancer patients have decreased concentration of butyrate-producing bacteria in their feces than healthy individuals (See for example, p. 6 right-hand column 1st paragraph). Riviere et al. also teach concentrations of microbiota comprising Anaerostipes spp. in colon of greater than 1011 bacteria per mL (See p. 3 figure 1, left-hand box, and related legend), and further teach method to determine the change (increase and decrease) in the number of bacteria including of Anaerostipes spp., etc. (See for example, Table 2., column headers “Method of bacterial characterization” and “bacterial shift”).
In addition, before the effective filing dated of the invention, Wood et al. teach technique of determining the relative abundance of bacteria in the sample and comparing the genotypic composition of bacterial populations in a sample (see for example, p. 3683 right-hand column “Materials and Methods”, and p. 3684 left-hand column).
Moreover, Syrop teaches febrile neutropenia is a complication of chemotherapy in cancer patients including colorectal cancer (See p. 1 1st and 2nd paragraphs), and it is also well-known in the art that diarrhea is a common side effect of chemotherapy.
Therefore, a person of ordinary skill in the art before the effective filing date of the invention knowing that Anaerostipes hadrus is among the important butyrate-producing bacteria species in human and that patients with cancer have decreased concentration of butyrate-producing bacteria in their feces than healthy individuals (as taught by Riviere et al.), and further that febrile neutropenia and diarrhea are complications of chemotherapy in cancer patients (as taught by Syrop), said person of ordinary skill in the art would have been capable of applying the techniques determining the relative abundance of bacteria in the sample and comparing the composition of bacterial populations in a sample (teachings of Wood et al. and Riviere et al.) in the method taught by Sato et al. with a reasonable expectation of success in providing the claimed method for determining a risk of an adverse event during multimodal treatment, comprising; measuring Anaerostipes hadrus in a sample collected from a subject and further comparing an occupancy rate of Anaerostipes hadrus in total bacteria in the sample with a reference value; and determining that the risk of an adverse event during the multimodal treatment is high when the occupancy rate is equal to or less than the reference value. The claimed method would have been obvious because Sato et al. teach a method for determining a risk of an adverse event during multimodal treatment, comprising; measuring Anaerostipes hadrus in a sample collected from a subject, Riviere et al. teach Anaerostipes hadrus is among the important butyrate-producing bacteria species in human and that patients with cancer have decreased concentration of butyrate-producing bacteria in their feces than healthy individuals, Syrop teaches febrile neutropenia is among the complication of chemotherapy in cancer patients, and further because Wood et al. teach technique of determining the relative abundance of bacteria in the sample and comparing the genotypic composition of bacterial populations in a sample.
Regarding claims 9 and 10:
Prior art does not teach the subject matter of claims 9 and 10, i.e., determining that a risk of febrile neutropenia during the multimodal treatment is high when a number of bacteria of Anaerostipes hadrus in the sample is 107.7 or less per gram of the sample or an occupancy rate of Anaerostipes hadrus in total bacteria in the sample is 0.25% or less (claim 9), and the method further comprising: determining that a risk of diarrhea during the multimodal treatment is high when a number of bacteria of Anaerostipes hadrus in the sample is 107.6 or less per gram of the sample or an occupancy rate of Anaerostipes hadrus in total bacteria in the sample is 0.084% or less (claim 10).
Conclusion(s):
No claim(s) is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KADE ARIANI whose telephone number is (571)272-6083. The examiner can normally be reached IFP, Monday - Friday, 8:00 AM -4:00 PM EST.
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/KADE ARIANI/Primary Examiner, Art Unit 1651
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