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 .
Claim Status
Applicant’s reply to the July 07, 2025 Office Action, filed on March 06 2025 is acknowledged.
Claims 1, 5-7 are cancelled.
Claim 9 is amended.
Priority
This application claims priority to and the benefit of Korean Patent Application No. 10-2021-0075890, filed on June 11, 2021.
Claim Objection
Claim 8 is objected to under 37 CFR 1.75(C) as being improperly dependent on cancelled claim 7.
Rejection withdrawn
The rejection of claim 7 under 35 U.S 112(d) is moot in view of Applicant’s cancelation of claim 7 in the reply filed July 07, 2025.
The rejection of claims 2-4, 7-10 under 35 U.S.C. 102(a)(1) as anticipated by Park, Frontiers in Veterinary Science, 2021, has been withdrawn in view of Applicant's Oath declaration in the reply filed July 07/2025.
The rejection of claims 2-4, 7-10 under 35 U.S 103 has been withdrawn in view of Applicant’s amendments to the claims in the reply filed July 07, 2025.
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.
Claim 8 is 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 8 is dependent on claim 7 thus rendering claim 8 indefinite as there is not antecedent basis for “the method of claim 7, wherein the kit…” as required by claim 8.
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 2-4, 8-10 are rejected under 35 U.S.C. 101 because the claimed inventions are directed to judicial exception(s) (i.e., a law of nature, a natural product, and/or an abstract idea) without significantly more. The rationale for this determination is explained below:
This rejection was made in the office action mailed March 06, 2025 and has been rewritten to address the amendments the claim in the reply filed July 07, 2025.
Claims 9 recites a method for diagnosing Johne's disease, comprising: i) measuring a protein level of alpha-2-macroglobulin (A2M) or an mRNA level thereof in a sample isolated from a subject by using a biomarker composition having an agent that includes at least one of nanoparticles that specifically bind to the protein and a probe including a labeled nucleic acid fragment; and ii) classifying as Johne's disease if the measured level is higher than a normal control level of about 25 ug/ml.
This judicial exception is not integrated into a practical application because the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Subject Matter Eligibility Test for Products and Processes
Step 1 - Is the Claim to a Process, Machine, Manufacture or Composition of Matter? YES.
The claims provide for a method comprising: i) measuring a protein level of alpha-2-macroglobulin (A2M) or an mRNA level thereof in a sample isolated from a subject by using a biomarker composition having an agent that includes at least one of nanoparticles that specifically bind to the protein and a probe including a labeled nucleic acid fragment; and ii) classifying as Johne's disease if the measured level is higher than a normal control level of about 25 ug/ml. Thus, the claims are directed to a statutory category (e.g., a process).
Step 2A, — Does the claim recite a Law of Nature, a Natural Phenomenon, or an Abstract idea? YES.
The Supreme Court has explained that the judicial exceptions reflect the Court’s view that abstract ideas, laws of nature, and natural phenomena are "the basic tools of scientific and technological work", and are thus excluded from patentability because "monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it". The claims recite two judicial exceptions. Claim limitation “Measuring a protein level of alpha-2-macroglobulin (A2M) or an mRNA level thereof in a sample isolated from a subject is a “natural phenomenon”. The relationship between the levels of alpha-2-macroglobulin or its mRNA and the diagnosis of Johne's disease is a natural phenomenon. The fact that the biomarker alpha-2-macroglobulin protein or its mRNA levels may correlate with a disease is considered a law of nature, as it is an inherent biological process that exists in the body independent of human intervention. The above claim limitation is an insignificant extra solution activity because it generally refers to data gathering activity, which is not considered to integrate the judicial exception into a practical application (see MPEP 2106.05(g)).
Claim limitation “classifying as Johne's disease if the measured level is higher than a normal control level of about 25 ug/ml” is not indicative of integration into a practical application. The above claim limitation is considered simply as the recitation of: 1) a “mental process” of evaluating/interpreting data/information; and 2) a relationship/correlation between biomarker levels and a comparison between biomarker levels and reference levels (i.e., natural principle). The “classifying” step relies on a naturally occurring correlation-specifically the recognition that elevated levels of biomarker (protein or mRNA) are associated with the presence of Johne’s disease. This step involves applying a threshold value (25 ug/ml) to determine the disease status, which is a mental step or natural law, the biological relationship between the marker level and the disease. In accordance with Mayo Collaborative v. Prometheus Lab., Inc., 566 U.S 66 (2012), the act of comparing a measured biomarker level to a control and drawing a diagnostic conclusion is considered a law of nature and is not, by itself, patent-eligible subject matter. There are no further/additional steps which applies either the identified judicial exceptions into a practical application. Thus, the claimed invention describes judicial exceptions, which correspond to natural phenomenon and natural principles.
Step 2B - Does the Claim Recite Additional Elements that Amount to Significantly More than the Judicial Exception? NO.
The Supreme Court has identified a number of considerations for determining whether a claim with additional elements amounts to “significantly more” than the judicial exception(s) itself. The claims as a whole are analyzed to determine whether any additional element/step, or combination of additional elements/steps, in addition to the identified judicial exception(s) is sufficient to ensure that the claim amounts to “significantly more” than the exception(s).
However, the additional elements of the instant application, individually and in combination, do not amount to “significantly more.” Under the Step 2B analysis, the “physical” elements/steps of “biomarker composition having an agent that includes at least one of nanoparticles that specifically bind to the protein or a peptide fragment and a probe including a labeled nucleic acid” tells a laboratory provider who works with ruminants to obtain a sample and detect the biomarker levels through whatever process the laboratory wishes to use. Further, these in addition to steps are “physical” steps (e.g., “providing a biological sample from a subject,” “detecting a biomarker in the sample”) are considered to be within the purview of one in the art as being routine and conventional in the art when evaluating and prognosing Johne’s disease in a subject.
Simply appending routine and conventional activities previously known to the industry specified at a high level of generality to the judicial exception and/or generally linking the use of the judicial exception(s) to a particular technological environment or field of use, are not found to be enough to qualify as “significantly more.” Nothing is added by identifying the methods to be used (i.e., “detecting alpha-2-macroglobulin in ruminants infected with Mycobacterium avium subsp. Paratuberculosis,”) because those techniques were well-understood, routine, and conventional techniques that a laboratory would have thought of when instructed to provide a diagnosis to an infected animal.
This information simply tells a veterinarian about the relevant natural law, at most adding a suggestion that the veterinarian should take those laws into account. Thus, when viewed both individually and as an ordered combination, the claimed elements/steps in addition to the identified judicial exception are found insufficient to supply an inventive concept because the elements/steps are considered conventional and specified at a high level of generality. The claim limitations do not transform the abstract idea that they recite into patent-eligible subject matter because “the claims simply instruct the practitioner to implement the natural phenomenon with routine, conventional activity.”
Regarding claim 2, the method of claim 9 to diagnose a disease that naturally occurs in ruminants does not transform the naturally occurring product into patent-eligible subject matter. According to MPEP 2106 and the Supreme Court decision in Mayo Collaborative services v. Prometheus Laboratories, Ins., the use of conventional agents to measure a naturally occurring protein, without further inventive steps or limitations, does not transform the claim into a patent-eligible subject.
Regarding claim 3, the claim that narrows the scope of claim 2, by specifying that ruminant is cattle, a goat, a sheep or a mountain goat. Merely specifying that the biomarker composition is used in particular ruminant cattle, a goat, a sheep or a mountain goat; does not add any meaningful limitations that may transform the natural product into a patent-eligible subject matter. The selection of these ruminant is not sufficient to confer eligibility.
Regarding claim 4, the correlation between the biomarker alpha-2-macroglobulin and the naturally occurring conditions clinical and subclinical infections of the ruminant represents a natural phenomenon. Specifying that the biomarker composition is used in ruminant that are clinically or subclinically infected does not add any inventive concept or meaningful limitations that may transform the natural phenomenon into a patent-eligible application. The act of comparing a measured level to a normal level and making a diagnosis is a mental process (See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012)). Mental processes and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work, MPEP 2106.04.
Regarding claim 8, the claim specifies different types of kits which are conventional tools used in the field of diagnostics. However, the recitation of these specific kits does not add an inventive concept or significantly more than the application of a product to diagnose a disease. In addition, the claimed kits are not directed to an improvement in the technology itself or a novel method of using these kits but rather are applied to a natural biological product.
Regarding claim 10, the claimed subject matter refers to a method that involves analyzing samples that are naturally occurring biological materials. These samples in their natural state, without any transformative steps, suggests that the claim is directed to a natural product. Merely specifying that the method uses samples such as blood, plasma, serum, lymph, cerebrospinal fluid, feces, isolated tissue, isolated cells and saliva, does not provide any inventive concept that transforms the natural product into a patent eligible application. The use of these samples in diagnostic methods represents a well know, routine practice that does not add significantly more to the underlying natural law.
Accordingly, the claims do not qualify as patent-eligible subject matter.
Response to Amendments and Arguments -35 U.S 101
With respect to the rejection of claims 2-4, 7-10 under 35 U.S.C 101, Applicant's amendments and arguments filed on July 07, /2025 have been fully considered but they are not persuasive.
Applicants assert that claim 9 “A method for diagnosing Johne's disease, comprising: i) measuring a protein level of alpha-2-macroglobulin (A2M) or an mRNA level thereof in a sample isolated from a subject by using a biomarker composition having an agent that includes at least one of nanoparticles that specifically bind to the protein or a peptide fragment and a probe including a labeled nucleic acid fragment; and ii) classifying as Johne's disease if the measured level is higher than a normal control level of about 25 pg/mL. Such a step is not merely a "mental process" of evaluating or interpreting data and information. In contrast, the control level had to be determined through experimentation as being a level indicative of Johne's disease, and signifies a contribution to the art”.
However, the claim limitation “classifying as Johne's disease if the measured level is higher than a normal control level of about 25 ug/ml” is not indicative of integration into a practical application. The above claim limitation is considered simply as the recitation of: 1) a “mental process” of evaluating/interpreting data/information; and 2) a relationship/correlation between biomarker levels and a comparison between biomarker levels and reference levels (i.e., natural principle). The “classifying” step relies on a naturally occurring correlation-specifically the recognition that elevated levels of biomarker (protein or mRNA) are associated with the presence of Johne’s disease. This step involves applying a threshold value (25 ug/ml) to determine the disease status, which is a mental step or natural law, the biological relationship between the marker level and the disease. In accordance with Mayo Collaborative v. Prometheus Lab., Inc., 566 U.S 66 (2012), the act of comparing a measured biomarker level to a control and drawing a diagnostic conclusion is considered a law of nature and is not, by itself, patent-eligible subject matter. There are no further/additional steps which applies either the identified judicial exceptions into a practical application. Thus, the claimed invention describes judicial exceptions, which correspond to natural phenomenon and natural principles.
Conclusion
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/JULIO WASHINGTON GOMEZ RODRIGUEZ/ Examiner, Art Unit 1637
/J. E. ANGELL, Ph.D./ Primary Examiner, Art Unit 1637