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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/20/2026 has been entered.
Claim Status
Claims 1-82 were canceled.
Claims 83-115 are pending and under consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/5/2026 is being considered by the Examiner. The signed IDS forms are attached with the instant office action.
It is noted that NPL document number 3 does not contain retrieved date or published date.
Withdrawn Rejections
Objection of claims 105 and 109 is withdrawn. Applicant amended the claims, thereby obviating this rejection/objection.
Rejection of Claims 83-115 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn. Applicant provided a persuasive argument.
MAINTAINED - 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 83-115 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 claims are directed to a judicial exception (natural phenomenon), specifically, the claims are drawn to a method to detect natural protein DPP3. Furthermore, the claims do not integrate said judicial exception into practical application, and the claims do not recite additional elements that amount to significantly more than said judicial exception.
The MPEP Section 2103 through 2106 provides a means of determining whether a particular claim is patent eligible under 35 U.S.C. 101.
Step 1 - Following a determination of the broadest reasonable interpretation of a claim, is the claim drawn to a process, machine, manufacture, or composition of matter? If the answer to this inquiry is “Yes,” the analysis moves on to step 2A.
Step 2A - A two-prong analysis. For prong one, does the claim recite an abstract idea, law of nature, or natural phenomenon? If “Yes,” the analysis proceeds to prong two, which asks whether the claim recites additional elements that integrate the judicial exception into a practical application. If “No,” the analysis moves on to step 2B.
Step 2B - Does the claim recite additional elements that amount to significantly more than the judicial exception? If “No,” the claim is not eligible subject matter under 35 U.S.C. 101.
In the instant case, the claims are drawn to a process, so the answer to Step 1 is “Yes.”
With respect to prong one of Step 2A, the answer is “Yes,” because as indicated above, the claims are drawn to a natural phenomenon, specifically, the claims are drawn to a method to detect natural product DPP3 and also abstract idea (e.g. mental process) of “determining whether the measured DPP3 concentration in the sample is above a predetermined threshold of DPP3 concentration.”
With respect to prong two of Step 2A, the claim does not recite additional elements that integrate the judicial exception into a practical application. In addition to the recited judicial exception, the claims recite steps of contacting the bodily fluid with a capture-binder and measuring a DPP3 concentration in the sample. However, these limitations relate to general methods of measuring DPP3 concentration in the sample and do not integrate the judicial exception into a practical application. Said limitations do not integrate the recited judicial exception, for example, by applying or using said judicial exception to effect a particular treatment for a disease or medical condition. Therefore, the answer to prong two of the Step 2A analysis is “No.”
With respect to Step 2B, using antibodies for detecting antigens, including DPP3, were well-understood, routine, and conventional data gathering steps that were practiced by investigators prior to Applicant’s invention. These steps do not amount to additional elements that amount to significantly more than the recited judicial exception. Accordingly, the answer to the Step 2B analysis is “No,” and therefore the claims are not eligible subject matter under 35 U.S.C. 101.
As discussed in nonfinal rejection 9/24/2025, Golz et al (WO2005/106486) teaches “Diagnostic tests for DPP3 include methods utilizing antibody and a label to detect DPP3 in human body fluids”. Therefore, detecting and measuring DPP3 concentration in the bodily fluid was well known in the art before the effective filing date of instant application.
It is suggested that Applicant amend independent claims to narrow the capture-binder to a specific monoclonal antibody to overcome this rejection. For example, reciting that the capture-binder is a monoclonal antibody comprising heavy chain comprising the sequence of SEQ ID NO: 12 and the light chain comprising the sequence of SEQ ID NO: 13 as claimed by US11530276 (PTO-892) will be considered as additional elements that amount to significantly more than the recited judicial exception and therefore will overcome this rejection.
A claim that focuses on use of a natural principle must also include additional elements or steps to show that the inventor has practically applied, and added something significant to, the natural principle itself. See Mayo, 101 USPQ2d at 1966. Recited elements such as “measuring” and "determining", based on the natural principle impose no meaningful limit on the performance of the claimed invention. Patents cannot be obtained on subject matter identified by the courts as being exempted from eligibility (i.e., laws of nature, natural phenomenon, and abstract ideas). Further, the active method steps are conventional and routine in the art for the reasons stated above and the claims do not amount to significantly more than the recited natural principle. The claims do not "practically apply" the natural principle; rather, the claims "simply inform" the natural principle to one performing routine active method steps and do not amount to significantly more than the natural principle itself. Thus, the technology used by the instant claims is well-known in the art and does not contribute significantly more to the judicial exception.
Response to Arguments
In the response filed on 8/20/2026, Applicant argued at page 19, “However, this reasoning overlooks that the claims recite "[a] method for preparing a sample for use in diagnosing in a subject a disease or condition that is accompanied by or related to necrotic processes, wherein the sample comprises bodily fluid from the subject and is prepared by ... " which is a practical application and not a natural phenomenon itself.”
Applicant's arguments have been fully considered but they are not persuasive. Instant claims recite active process steps of (i) contacting the bodily fluid with a capture-binder; (ii) measuring a DPP3 concentration in the sample, and (iii) determining whether the measured DPP3 concentration in the sample is above a predetermined threshold of DPP3 concentration. None of these active process steps recite practical application of the recited judicial exception.
Conclusion
No claim is allowed.
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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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