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 .
Priority
The Examiner acknowledges the Applicant’s explanation regarding the instant specification of this national stage application necessarily being a direct English translation of PCT/JP2021/018511. Therefore, 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 November 10th, 2025 is acknowledged. Regarding the Office Action mailed August 7th, 2025:
The objections to the specification are withdrawn in view of the amendments.
The rejection set forth under 35 U.S.C. 112(b) is withdrawn in view of the amendments.
The rejection set forth under 35 U.S.C. 102 is withdrawn in view of the priority benefit to May 14th, 2021.
Maintained or modified rejections are set forth below. Responses to arguments, if necessary, follow their respective rejection sections.
Claim Summary
Claim 1 has been amended. Claim 4 has been canceled. Claims 1-3 and 5-10 are pending. Claims 1-3 and 5-10 are under examination and discussed in this Office action.
Claim Rejections - 35 USC § 101 – Modified – Necessitated by Argument
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 1-3 and 5-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon and abstract ideas without significantly more. While the claims are directed to a process, and therefore meet step 1 of the subject matter eligibility test (see MPEP 2106.03), the claims recite the natural correlation between expression level of genes and Parkinson’s disease, as well as the abstract ideas of comparing measured values to reference values and preparing a discriminant. The correlation is a natural phenomenon because it describes a consequence of natural processes in the human body (e.g. expression levels of genes as they relate to disease). The abstract idea of comparing can potentially be a mental process. The abstract idea of preparing a discriminant is a mathematical concept.
Step 2A of the subject matter eligibility test requires a two-pronged analysis. Prong One asks: does the claim recite an abstract idea, law of nature or natural phenomenon? As discussed in MPEP 2106.04(II)(A)(1), the meaning of “recites” is “set forth” or “describes”. That is, a claim recites a judicial exception when the judicial exception is “set forth” or “described” in the claim. In the instant case, the claims describe a natural phenomenon and abstract ideas: the natural correlation between the gene expression and Parkinson’s disease, the mental process of comparing, and the mathematical concept of preparing a discriminant.
Prong Two of the analysis under step 2A asks: does the claim recite additional elements that integrate the judicial exception into a practical application of the judicial exception? As discussed in MPEP 2106.04(II)(A)(2), “Because a judicial exception is not eligible subject matter, Bilski, 561 U.S. at 601, 95 USPQ2d at 1005-06 (quoting Chakrabarty, 447 U.S. at 309, 206 USPQ at 197 (1980)), if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application. See, e.g., RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract"); Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016) (eligibility "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself."). For a claim reciting a judicial exception to be eligible, the additional elements (if any) in the claim must "transform the nature of the claim" into a patent-eligible application of the judicial exception, Alice Corp., 573 U.S. at 217, 110 USPQ2d at 1981, either at Prong Two or in Step 2B.” The considerations to be used are set forth at MPEP 2106.05(a) through (c) and (e) through (h). Turning to those sections of the MPEP:
MPEP 2106.05(a) has to do with improvements to the functioning of a computer or to any other technology or technical field. The claims at issue do not improve the functioning of a computer or other technology. While the instant claims recite steps of measuring mRNA expression levels of one or more specific genes, comparing measured expression levels with reference expression levels, and comparing measured expression levels with reference expression levels via a discriminant, the claims do not improve upon mRNA extraction techniques, determination of mRNA expression levels, or comparison techniques of measured and reference values. The claims merely use existing methods for these steps. Note that MPEP 2106.05(a) indicates that “[u]sing well-known standard laboratory techniques to detect enzyme levels in a bodily sample” is an example that the courts have indicated may not be sufficient to show an improvement to technology.
MPEP 2106.05(b) has to do with whether the claims involve the use of a particular machine. In this case, the claims do not involve the use of a particular machine. While the instant claims recite steps of measuring mRNA expression levels of one or more specific genes, comparing measured expression levels with reference expression levels, and comparing measured expression levels with reference expression levels via a discriminant, no such machines are required by the claim, and certainly no particular machines. Even if some conventional machine were recited in the claims, such as a PCR machine, further considerations such as the particularity or generality of the recited machine must be taken into account, as well as whether the involvement of the machine is merely extra-solution activity. MPEP 2106.05(g) describes “extra-solution activity”, noting that “[d]etermining the level of a biomarker in blood” is an example of “mere data gathering” which the courts have found to be insignificant extra-solution activity.
MPEP 2106.05(c) has to do with whether the claims involve a particular transformation. Here, none of the limitations of the claims involve a particular transformation. For example, the collection of RNA from a skin surface lipid sample does not transform that RNA into something else.
MPEP 2106.05(e) has to do with “other meaningful limitations”. The additional limitations imposed upon the natural correlation between the gene expression and Parkinson’s disease, the mental process of comparing, and the mathematical concept of preparing a discriminant in the instant case have to do with measuring mRNA expression levels of one or more specific genes, comparing measured expression levels with reference expression levels, and comparing measured expression levels with reference expression levels via a discriminant. These limitations are not considered “meaningful limitations”. MPEP 2106.05(e) states: “The phrase "meaningful limitations" has been used by the courts even before Alice and Mayo in various contexts to describe additional elements that provide an inventive concept to the claim as a whole.” However, these limitations do not arrive at an inventive concept. In addition, as has been discussed, they represent insignificant extra-solution activity, i.e. “data gathering”.
MPEP 2106.05(f) raises the question as to whether the additional elements recited in the claim represent “mere instructions to apply an exception”. Here, the judicial exceptions are the natural correlation between the gene expression and Parkinson’s disease, the mental process of comparing, and the mathematical concept of preparing a discriminant. The additional elements recited in the claims (i.e. measuring mRNA expression levels of one or more specific genes, comparing measured expression levels with reference expression levels, and comparing measured expression levels with reference expression levels via a discriminant) do amount to mere instructions to apply the correlation, since the collection of particular samples, measuring expression of mRNA from those samples, comparing measured expression levels with reference expression levels, and comparing measured expression levels with reference expression levels via a discriminant serve as mere conventional steps taken for the purpose of gathering data about the gene expression levels of genes associated with Parkinson’s disease, which any practical use of the judicial exceptions would require.
MPEP 2106.05(g) has to do with whether the additional elements of the claim amount to insignificant extra-solution activity. MPEP 2106.05(g) notes that “[d]etermining the level of a biomarker in blood” is an example of “mere data gathering” which the courts have found to be insignificant extra - solution activity. Likewise, MPEP 2106.05(g) notes that “[p]erforming clinical tests on individuals to obtain input for an equation” also represents insignificant extra-solution activity. This aligns closely with the instant claims, where the additional elements of the claims amount to measuring mRNA expression levels of one or more specific genes, comparing measured expression levels with reference expression levels, and comparing measured expression levels with reference expression levels via a discriminant.
MPEP 2106.05(h) has to do with whether the additional elements amount to more than generally linking the use of a judicial exception to a particular technological environment or field of use. Here, the recitation of the method being used to detect Parkinson’s disease is considered a “field of use”. However, as MPEP 2106.05(h) indications, such limiting to a particular “field of use” does not confer patentability on otherwise ineligible subject matter.
Having considered the factors discussed in MPEP 2106.05 (a)-(c) and (e)-(h), it is clear that the additional elements recited in the claims, whether considered individually or as a combination, do not integrate the judicial exceptions into a practical application of those exceptions in such a way as to provide meaningful limits on the use of the judicial exceptions. Therefore, claims 1-3 and 5-10 are rejected here under 35 U.S.C. 101.
Response to Arguments
Applicant's arguments filed November 10th, 2025 have been fully considered but they are not persuasive.
The Applicant argues that the presently claimed method is a marked improvement over prior tests for detecting Parkinson’s disease, which are more invasive and require blood samples (Page 17 of the Remarks filed November 10th, 2025). The Applicant then summarizes aspects of the disclosure included in the Examples in the specification (Pages 17-18 of the Remarks filed November 10th, 2025). The Applicant also states that the Uehara publication supports the claimed invention as a marked improvement over prior tests for detecting Parkinson’s disease (Page 18 of the Remarks filed November 10th, 2025).
In response, the Examiner would first like to address the prior art. Given the change in priority indicated above, the art is no longer applicable to the 101 rejection. However, this does not change the issues still found in the claims as currently written. While the sample type may be a non-invasive skin surface lipid, ultimately it still amounts to using well-known standard laboratory techniques to detect levels of mRNA in a bodily sample, which is very similar to Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1355, 1362, 123 USPQ2d 1081, 1082-83, 1088 (Fed. Cir. 2017), wherein “[u]sing well-known standard laboratory techniques to detect enzyme levels in a bodily sample such as blood or plasma” was indicated as not sufficient to show an improvement to technology (see MPEP 2106.05(a)(II)). With no additional details to integrate the exceptions into a practical application, and given the full breadth of the rejection above, the claims are still representative of a natural phenomenon and abstract ideas without significantly more. Furthermore, the Uehara publication cannot provide support for marked improvement as it is a paper outside of the documentation provided for the instant case. Therefore, the Applicant’s arguments are not considered persuasive and the rejection under 35 U.S.C. 101 is maintained.
Conclusion
All claims are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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/ALLISON E SCHLOOP/ Examiner, Art Unit 1683
/ANNE M. GUSSOW/ Supervisory Patent Examiner, Art Unit 1683