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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Current Status of 17-271,981
This Office Action is responsive to the arguments and amendments received 10 June 2026.
Claims 17, 59, and 61-64 are currently pending.
Election/Restrictions
Applicant’s election without traverse of Group I, being claims 1-5, 9-12, 17, 20, 22, 33, 36 and 38-40 in the reply filed on 18 March 2024 is acknowledged.
The elected group has been determined to read on claims 17, 59, and 61-64. No claims are currently withdrawn due to the restriction requirement.
Priority
Applicant’s claim for the benefit of the prior-filed patent applications PCT/US2019/048818 (filed 29 August 2019) and US 62-724,337 (filed 29 August 2018) under 35 U.S.C. 119(e), 120, 121, 365(c), or 386(c) is acknowledged.
Response to Amendments
The objections to the claims, present in the previous rejection, are hereby withdrawn due to Applicant’s amendments.
The 35 U.S.C. 112 rejections to the claims, present in the previous office action, are hereby withdrawn herein due to Applicant’s amendments.
The 35 U.S.C. 101 rejections to the claims, present in the previous office action, are maintained herein.
The 35 U.S.C. 103 rejections to the claims, present in the previous office action, are withdrawn herein due to Applicant’s amendments.
Response to Arguments
Applicant's arguments received 10 June 2026 have been fully considered.
Applicant argues that the judicial exception present in claim 17 is integrated into a treatment for a disease. Applicant argues that claim 17 recites the detection of a specific expression profile and the treatment of expression profiles in steps (i)-(iii). Applicant argues that methods of treatment are patent eligible. Applicant argues that claim 17 recites: measuring gene expression levels, detection of a specific expression profile, and administering treatments for specific expression profiles. Applicant argues that claim 17 does not allow for only the measurement step to be performed, because steps (i)-(iii) require detection of specific expression profiles and the treatment of those expression profiles.
As currently written, claim 17 first requires measuring the expression levels of MGMT, GPRASP1, CHGA, MAPK8, ATP6V0A2, and FGF7. Then in additional steps, the claim requires the treatment of three particular expression profiles with three differing treatments. This sets up a possible avenue through the claim that is not addressed by the claim itself. If the measurement step is performed, but none of the specific expression profiles of steps (i)-(iii) are found, what does the artisan then do? It appears possible that the measuring step alone is within the scope of claim 17, and so the Examiner has rejected claim 17 and the claims dependent thereupon under 35 USC 101.
The Examiner sees the following potential solution that Applicant may consider. Claim 17 may be rewritten generally in the reverse order relative to its current state. After the preamble and transitional phrase, claim 17 could recite the three treatment options with their associated required expression profiles, and a “wherein” clause at the bottom of the claim could describe the measurement of the expression levels of MGMT, GPRASP1, CHGA, MAPK8, ATP6V0A2, and FGF7 from a glioblastoma tumor sample, including the required centering and scaling. In this way, the reader would not see any “measurement-only” scenarios within the scope of the claim.
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 17, 59, and 61-64 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The method of instant claim 17 requires a step of measuring the expression levels of several genes and requires particular therapies to be applied if specific expression profiles are present within the tumor sample. Because there are many expression profiles that are not mentioned within the claim (for example CHGA and MAPK8 being decreased), claim 17 seems to implicitly state that if any non-enumerated expression profile is determined to be present, only the expression level measuring step will be performed. Those embodiments of claim 17 are directed to measurement of naturally occurring concentrations, without adding significantly more. This judicial exception is not integrated into a practical application, because no other actions are required by these embodiments of the claim. The measurement of all expression levels within a cell or population of cells was well-known within the literature before the instant effective filing date. ZHAO (Previously cited by the Examiner, Zhao, S.; Fung-Leung, W.; Bittner, A.; et al. “Comparison of RNA-Seq and Microarray in Transcriptome Profiling of Activated T Cells” PLOS ONE | January 2014 | Volume 9 | Issue 1 | e78644) compares the benefits of RNA-Seq and microarray technology in transcriptome profiling (abstract), and transcriptome profiling is a method of determining the expression of all RNA transcripts within a cell or cell population. See MPEP 2106.05.
The following is an excerpt from MPEP 2106.05(d): In Mayo, the claims at issue recited naturally occurring correlations (the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that a drug dosage will be ineffective or induce harmful side effects) along with additional elements including telling a doctor to measure thiopurine metabolite levels in the blood using any known process. 566 U.S. at 77-79, 101 USPQ2d at 1967-68. The Court found this additional step of measuring metabolite levels to be well-understood, routine, conventional activity already engaged in by the scientific community because scientists “routinely measured metabolites as part of their investigations into the relationships between metabolite levels and efficacy and toxicity of thiopurine compounds.” 566 U.S. at 79, 101 USPQ2d at 1968. Even when considered in combination with the other additional elements, the step of measuring metabolite levels did not amount to an inventive concept, and thus the claims in Mayo were not eligible. 566 U.S. at 79-80, 101 USPQ2d at 1968-69.
Conclusion
No claims are currently allowable.
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 JOHN D MCANANY whose telephone number is (571)270-0850. The examiner can normally be reached 8:30 AM - 5:30 PM.
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/JDMc/Examiner, Art Unit 1625
/Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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