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 1-4) in the reply filed on June 18, 2026 is acknowledged. Applicant's election without traverse of homoarginine as the species to be examined in claims 1-4, and of histidine (His) as the species to be examined in claims 2 and 4 in the reply filed on June 18, 2026 is also acknowledged. Claims 5-10 are withdrawn from further consideration.
Applicants are requested to amend the claims to reflect the elected species of homoarginine and His. The Examiner has searched and examined the claims in light of only the elected species.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The disclosure is objected to because of the following informalities: In the first paragraph on page 1 of the specification (Cross-Reference to Related Application), the phrase –now abandoned—should be inserted after the phrase “U.S. Application No. 15/715,389, filed September 26, 2017” so as to update the status of this parent application.
Appropriate correction is required.
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 1-14 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 is indefinite since the only step of the method constitutes a mental step of evaluation based on a concentration value of homoarginine (the elected species) without any positive, active steps in the method. It is unclear how the concentration value of homoarginine is obtained or measured in order to be evaluated in the method. Claim 1 is also indefinite since it is not clear how lung cancer is “evaluated” in the method using the concentration value of homoarginine. Is the concentration value of homoarginine compared to some predetermined threshold level of homoarginine that represents either the presence or absence of lung cancer in a reference subject in order to “evaluate” a state of lung cancer in the subject under evaluation? It is unclear how the concentration value of homoarginine is “used” to “evaluate” lung cancer in the subject.
Claim 2 is indefinite since it is unclear how the concentration value of histidine (the elected species) is obtained or measured in order to be evaluated in the method. Claim 2 is also indefinite since it is not clear how lung cancer is “evaluated” in the method using the concentration value of histidine. Is the concentration value of histidine compared to some predetermined threshold level of histidine that represents either the presence or absence of lung cancer in a reference subject in order to “evaluate” a state of lung cancer in the subject under evaluation? It is unclear how the concentration value of histidine is “used” to “evaluate” lung cancer in the subject. See these same problems in claim 4.
On lines 3-5 of claim 3, the phrase “by calculating a value of a formula further using the formula including an explanatory variable to be substituted” is indefinite since it does not make proper sense. Is a value of the formula calculated by substituting a concentration value of homoarginine for an explanatory variable in the formula? Claim 3 is also indefinite since it is not clear what the “formula” is that is used to calculate the recited “value”. Without knowing what specific formula is used to calculate the value used to evaluate the state of lung cancer in the subject, one of ordinary skill in the art would not know how to perform the method, and would not know whether they are infringing on the method or not. See this same problem in claim 4.
Inventorship
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.
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 1-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claim(s) recite(s) the natural correlation or phenomenon between a concentration of homoarginine and His present in a blood sample from a subject and a presence of lung cancer in the subject. This judicial exception is not integrated into a practical application because the claims do not apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment or field of use. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
In Mayo v. Prometheus Laboratories, the Supreme Court held that the relationships between concentrations of certain metabolites in the blood and the likelihood that a thiopurine drug dosage will prove ineffective or cause harm are not themselves patent eligible. The claimed processes are likewise not patent-eligible unless they have additional features that provide practical assurance that the processes are genuine applications of those laws rather than drafting efforts designed to monopolize the correlations. Claims, particularly process claims, cannot be directed to such ineligible subject matter. In addition, to be patent eligible, a claim that includes an exception should include other elements or combination of elements such that, in practice, the claimed product or process amounts to significantly more than a law of nature, a natural phenomenon, or an abstract idea with conventional steps specified at a high level of generality appended thereto.
In the instant case, the claims are drawn to the natural correlation between a concentration of homoarginine and His in blood of a subject and a state of lung cancer in the subject. A determination of a relationship between the concentration of these biomarkers in a blood sample from a subject and a presence of lung cancer in the subject is not considered to be significantly more than the natural phenomenon itself. The relationship between the biomarkers comprising homoarginine and His and a presence of lung cancer in a subject exists in principle and in nature apart from any human action. The relationship between the biomarkers and a presence of lung cancer in a subject is a natural consequence of lung cancer in the body of the subject. The steps of the recited methods are not sufficient to narrow the application such that others could still make use of the naturally occurring correlation in other practical applications. The claims essentially set forth a law of nature with generalized instructions to apply it. Therefore, the claims are directed to ineligible subject matter and are unpatentable under 35 USC 101.
When considering the claims under the 2019 Revised Patent Subject Matter Eligibility Guidance (January 2019), it is noted that the claims meet step 1 of the guidance since the claims are directed to one of the statutory categories of invention (i.e. are directed to a process). The claims meet prong one of revised step 2A since the claims recite a natural phenomenon between homoarginine and His, and a presence of lung cancer in a subject, which constitutes a judicial exception. The claims do not meet prong two of revised step 2A since the claims do not recite additional elements that integrate the judicial exception into a practical application. With regards to claims 1 and 2, the step of “evaluating a concentration value” of homoarginine and His relates only to a mental analysis step that can be performed in the human mind, and claims 1 and 2 do not recite any additional elements beyond the judicial exception that integrate the judicial exception into a practical application under prong two of step 2A. With regards to claims 3 and 4, the step of “calculating a value of a formula” by substituting the concentration values of homoarginine and His into the formula also does not integrate the judicial exception into a practical application since the calculation of the value of the formula represents an abstract idea (i.e. a mathematical formula or equation) that is another type of judicial exception itself. This abstract idea or mathematical formula is not recited with any particularity, and it does not recite any additional elements or combination of additional elements that apply, rely on or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. Therefore, overall, none of the claims recite other meaningful limitations in addition to the judicial exceptions recited (i.e. both the natural correlation and the abstract idea/mathematical formula) which integrate the judicial exceptions into a practical application, and for this reason, the claims do not meet prong two of step 2A of the 35 USC 101 guidance and are ineligible under 35 USC 101.
It is also noted that the claims do not meet step 2B of the 35 USC 101 guidance since the claims do not recite any additional elements that are not well-understood, routine, and conventional. The claims only recite the judicial exceptions themselves with no steps or elements that are in addition to the judicial exceptions.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Please make note of: Arashida et al (US 2018/0017570) who teach of an evaluating method and apparatus for determining a state of lung cancer for a subject, and which corresponds to the parent application of this application; and Imaizumi et al (US 9,664,681) who teach of a lung cancer evaluating method and apparatus that measures concentrations of the amino acids lysine and histidine in a blood sample of a subject.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN M WALLENHORST whose telephone number is (571)272-1266. The examiner can normally be reached on Monday-Thursday from 6:30 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander, can be reached at telephone number 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAUREEN WALLENHORST/Primary Examiner, Art Unit 1797 July 2, 2026
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