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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 8th, 2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Priority
As indicated in the previous Office Action, for the purposes of examination and art rejections in this Office Action, the instant claims receive at least the benefit of the PCT filing date May 14th, 2021.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Response to Amendment
The amendment filed June 22nd, 2026 is acknowledged. Regarding the Office Action mailed January 20th, 2026:
The rejection set forth under 35 U.S.C. 101 is withdrawn in view of the amendments.
New grounds of rejection are set forth below, as necessitated by the amendments.
Claim Summary
Claim 1 has been amended. Claims 4-5 and 11-13 have been canceled. Claims 14-18 have been added. Claims 1-3, 6-10, and 14-18 are pending. Claims 1-3, 6-10, and 14-18 are under examination and discussed in this Office action.
Claim Rejections - 35 USC § 112(b) – New – Necessitated by Amendment and Further Considerations
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 6-10 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 6 recites the limitation “preparing a discriminant which discriminates between the Parkinson's disease patient and a healthy person by using measurement values of an expression level of the gene or the expression product thereof derived from a Parkinson's disease patient and an expression level of the gene or the expression product thereof derived from a healthy subject as teacher samples; substituting the measurement value of the expression level of the gene or the expression product thereof obtained from the biological sample collected from the test subject into the discriminant; and comparing the obtained results with a reference value.” This method of determining the presence or absence of Parkinson’s disease appears to conflict with the method of determining the presence of Parkinson’s disease as claimed in claim 1. Claim 1 recites the limitation “wherein presence of Parkinson’s disease is detected in the test subject when a measured expression level of the at least one gene or expression product thereof is increased compared with a control level of the at least one gene or expression product thereof”. Claim 1 does not involve a discriminant derived from an expression level of the gene or expression product from a Parkinson’s disease patient and an expression level of the gene or expression product from a healthy subject, and also does not involve inputting an expression level of the test subject into the discriminant. Claim 1 only requires a simple increased expression level of a subject as compared with a control level. It is unclear if the discriminant as described in claim 6 serves to determine expression being increased compared to a control level as there is no indication of an increase required in claim 6, nor a direct comparison between a test subject and a control. Furthermore, claim 6 states that the discriminant is discriminating between a Parkinson’s patient and a healthy person, and then comparing to a reference value. There is no reference to a control value as claimed in claim 1, and it is further unclear if the levels from the healthy person or reference value may be representative of the control level, or if they provide entirely different values.
Claim 6 also recites the limitations “the presence or absence of Parkinson’s disease”, which is not earlier introduced, and "the Parkinson’s disease patient", which is presented before introducing “a Parkinson’s disease patient”. There is insufficient antecedent basis for these limitations in the claim.
Claim 6 also recites the limitation “the test subject”, and then later recites “the Parkinson’s disease patient”. It is unclear from these recitations if the test subject is intended to be the Parkinson’s disease patient or if the test subject is different from the Parkinson’s disease patient. If the test subject is also the Parkinson’s disease patient, it is further unclear how a discriminant would serve to discriminate the test subject given the test subject is already known to have Parkinson’s disease.
Given these identified issues, claim 6 is found to be indefinite. Claims 7-10 are also rejected here for their dependence on claim 6 and not further clarifying the identified issues.
Allowable Subject Matter
Claims 1-3 and 14-18 are free of the prior art.
Conclusion
Claims 6-10 are rejected. Claims 1-3 and 14-18 are free of the prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Allison E Schloop whose telephone number is (703)756-4597. The examiner can normally be reached Monday-Friday 8:30-5 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571) 272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALLISON E SCHLOOP/Examiner, Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
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