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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/15/2026 and 03/25/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of invention I drawn to claims 1-17, and claims 18-20 withdrawn from further consideration as being drawn to non-elected inventions in the reply filed on 06/15/2026 is acknowledged.
Claim Objections
Claims 3-7 and 14-17 are objected to because of the following informalities: the phrase “A method” in line 1 of each claim should be amended to read –The method--. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: the phrase “single a fasting single” in line 5 should be amended to read –a fasting single--. Appropriate correction is required.
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 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
STEP 1: claims 1 and 12 recites a series of steps or acts to assess/monitor breath sample. Thus, the claims are directed to a process. which is one of the statutory categories of invention.
STEP 2A PRONG ONE: Claims 1 and 12 recite(s) specific limitations/method steps of: obtaining a fasting single breath sample from the subject, wherein the subject is undergoing treatment for intestinal methanogen overgrowth (IMO) or has undergone treatment for IMO; measuring the methane concentration in the fasting single breath sample; comparing the methane concentration to an initial breath methane concentration from the subject or a previous breath methane concentration from the subject, detecting a decrease in the methane concentration in the fasting breath sample compared to the initial breath methane concentration, or compared to the previous breath methane concentration, or detecting a stable methane concentration in the fasting breath sample compared to the initial breath methane concentration, or compared the previous breath methane concentration, or detecting an increase in the methane concentration in the fasting breath sample compared to the initial breath methane concentration, or compared to the previous breath methane concentration, or detecting a methane concentration of less than 10 ppm.
These limitations recite a mental process, because the claimed limitation describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). For example, a caregiver can compare methane concentration to previous sample breath and determine health state of the patient. Thus, the claims are drawn to a Mental Process, which is an Abstract Idea. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human, or using simple pen/paper.
STEP 2A PRONG TWO: Claims 1 and 12 does not recite any additional elements that integrates the judicial exception into a practical application.
Accordingly, claims 1 and 12 does not recite any additional elements beyond the judicial exception and do not integrate the abstract idea into a practical application as they fail to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception.
STEP 2B: Claims 1 and12 does/do not include any additional structural elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements.
Accordingly, the recited limitations do not integrate the abstract idea into a practical application as they fail to recite additional element(s) or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception.
When viewed alone or in combination, the limitations of claims 1-17 merely instruct the practitioner to implement the concept of collecting data with routine, conventional activity specified at a high level of generality in a particular technological environment. The inventive concept cannot be furnished by the abstract idea; instead, the application must provide something inventive, beyond mere “well-understood, routine, conventional activity” (Genetic Technologies Limited v. Merial L.L.C.). The additional elements of independent claims when viewed alone or as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea and does not amount to significantly more than the abstract idea itself. In other words, this claim merely applies an abstract idea to a computer and does not (i) improve the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, claims 1-20 are not patent eligible under 35 USC 101.
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 1-17 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 1 recites the limitation "the methane concentration" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the methane concentration" in line 6. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-17 is/are rejected under 35 U.S.C. 103 as being obvious over Soffer et al (US 2020/0386739).
As to claims 1 and 12, Soffer teaches a method of monitoring breath methane concentration in a subject and assessing treatment response in a subject (abstract, par.9-10, par.23 and par.33-38), comprising:
obtaining a fasting breath sample from the subject (breath taken while fasting, par.20 and par.36), wherein the subject is undergoing treatment for intestinal methanogen overgrowth (IMO) or has undergone treatment for IMO (breath taken while taking antibiotics, par.20, par.23, par.30 and par.33-38);
measuring the methane concentration in the fasting single breath sample (determining methane concentration in breath taken after fasting, par.36-38);
comparing the methane concentration to an initial breath methane concentration from the subject or a previous breath methane concentration from the subject (par.34, Examiner respectfully notes that patients showing methane level increased or decreased must be compared to previous breath samples),
detecting a decrease in the methane concentration in the fasting breath sample compared to the initial breath methane concentration, or compared to the previous breath methane concentration ((A) patients who are methane producers who do show a methane response to antibiotic treatment; (B) patients who are methane producers who do not show a methane response to antibiotic treatment, par.33-34 and par.36-38, Examiner respectfully notes patients that show response to antibiotic treatment will inherently show a drop in methane production as, par.33), or
detecting a stable methane concentration in the fasting breath sample compared to the initial breath methane concentration, or compared the previous breath methane concentration ((A) patients who are methane producers who do show a methane response to antibiotic treatment; (B) patients who are methane producers who do not show a methane response to antibiotic treatment, par.34 and par.36-38, Examiner respectfully notes that stable methane producers who don’t show methane response can be interpreted as being at stable level and/or a decrease in methane level), or
detecting an increase in the methane concentration in the fasting breath sample compared to the initial breath methane concentration, or compared to the previous breath methane concentration ((A) patients who are methane producers who do show a methane response to antibiotic treatment; (B) patients who are methane producers who do not show a methane response to antibiotic treatment, par.34 and par.36-38, Examiner respectfully notes that patients that produces methane are patients who do not response to antibiotic treatment, and inherently production of methane will increase), or
detecting a methane concentration of less than 10 ppm (level of exhaled breath methane (eCH4) of ≥10 PPM is considered to be positive (35), par.10, par.17 and par.36).
Soffer teaches the invention substantially as claimed above, but failed to explicitly teach the fasting breath was a single fasting breath sampled, and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art, In re Aller, 105 USPQ 233. So, it would have been obvious to one having an ordinary skill in the art to instruct the patient to give only one single breath to obtain more accurate results.
As to claims 2 and 13, Soffer teaches the method, wherein the initial breath methane concentration from the subject is from a lactulose breath test, from a glucose breath test, or from a single fasting single methane measurement, or wherein the previous breath methane concentration from the subject is from a lactulose breath test, from a glucose breath test, or from single a fasting single methane measurement (a single, spot collection, analysis could consist of a number of breath samples consisting of a baseline sample, collected after fasting, followed by, but not limited to, ingestion of a carbohydrate such as lactulose, par.16, par.20 and par.36).
As to claims 3 and 14, Soffer teaches the method, further comprising performing all the method steps two or more times (Collections can be repeated every 5 minutes to every day, par.20, par.34, repeated test, par.36, and subjects will have repeated breath tes 38).
As to claims 4-6 and 15-17, Soffer teaches the method, further comprising performing all the method steps two or more times for about 7-14 days, two or more times for about 10 days, and/or performed once per day. Soffer teaches the breath sampling test can be repeated every 5 minutes to every day, such as, but not limited to every 5 minutes, 15 minutes, 90 minutes, 120 minutes, 150 minutes, 240 minutes or 1440 minutes (par.20), and that treatment can take from 1-90 days to reduce methane production (which means repeated testing, par.26-28), but failed to explicitly teach all the method steps two or more times for about 7-14 days, two or more times for about 10 days, and/or performed once per day. However, it would have been obvious to one having an ordinary skill in the art at the time the invention was made to repeat the breath sampling test based on each patient condition, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art, In re Aller, 105 USPQ 233.
As to claim 7, Soffer teaches the method, wherein detecting a decrease in the methane concentration in the fasting breath sample compared to the initial breath methane concentration, or compared to the previous breath methane concentration indicates that the treatment for IMO is effective (to evaluate the patient as methane positive is by identifying 10 ppm or greater of methane in the patient's breath. It can be useful to evaluate intestinal methanogenic archaea or breath methane, before, after or during treatment, par.10, and/or dosages for other antibiotic agents that can reduce the level of methanogenic archae in the patient's digestive tract can be determined based on effective doses for other treatments and titrating the patient until methane levels are reduced, par.30), or
detecting a stable methane concentration in the fasting breath sample compared to the initial breath methane concentration indicates that the treatment for IMO is ineffective, or
detecting a stable methane concentration in the fasting breath sample compared the previous breath methane concentration indicates that the treatment for IMO is effective, or
detecting an increase in the methane concentration in the fasting breath sample compared to the initial breath methane concentration, or compared to the previous breath methane concentration indicates that the treatment for IMO is ineffective, or
detecting a methane concentration of less than 10 ppm is indicative of the treatment for IMO is effective.
As to claims 8-11, Soffer teaches the method, wherein treatment may take various days and different dosages and various different medications (para[0026]-[0029]) and further that some may not respond to treatment (para[0034]: (B) patients who are methane producers who do not show a methane response to antibiotic treatment"), but failed to explicitly teach having the subject continue to treatment for IMO if the treatment is effective, having the subject stopping the treatment for IMO if the treatment is ineffective, having the subject change the treatment for IMO if the treatment is ineffective or there is recurrence of IMO, and having the subject stop the treatment for IMO if the methane concentration is less than 10 ppm.
Since such a modification would amount to applying a known technique (i.e. administering different medication doses and/or different type of medications to treat a disease) to a known method (i.e. treating a disease) ready for improvement to achieve a predictable result such as continuing medication if effective and stopping medication if not effective (see par.20-29 and 34-38 of Soffer)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations), so it would have been obvious to one having an ordinary skill in the art before the effective filing date of the invention to try to stop treatment if not effective to reduce methane production, and to continue treatment if methane production is reduced.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY A ABOUELELA whose telephone number is (571)270-7917. The examiner can normally be reached 8-5.
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/MAY A ABOUELELA/Primary Examiner, Art Unit 3791
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