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 .
Drawings
The drawings are objected to because Figure 3A contains text that is illegible. See gen labels on panels 9-16. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 24, 26, 28, 33, and 34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon and abstract idea judicial exceptions without significantly more. The claim(s) recite(s) the relationship between gene expression levels and likelihood of recurrence of meningioma which is a correlation that exists in nature, and thus is a natural phenomenon. “Assigning” an expression score to a normalized value could be done in the mind, and thus is a mental process. Finally, the claims recite mathematical calculations (determining normalized value, summing expression scores). This judicial exception is not integrated into a practical application because the step in addition to the judicial exceptions are data gathering steps and do not apply or use the exceptions in any way. The final process step of “recommending radiotherapy” is a generic broad step that does not actually effect any particular treatment of prophylaxis. It is a statement to “apply” the judicial exceptions.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the step in addition to the judicial exceptions (i.e. detecting levels of expression) is a data gathering step recited at an extremely high level of generality. Methods for determining gene expression were well-established, routine and conventional at the time of the invention, see for example VanGuilder which discusses 25 years of quantitative PCR for gene expression analysis, from 2008.
The claims include an additional step of recommending radiotherapy to the patient “when” the patient has a high-risk score. This step is conditional, and is only required to be practiced if a patient has a certain score, and the claim does not require observing that the patient does in fact have that score. For this reason, it does not integrate the claim or provide a significant step in addition to the judicial exception. Furthermore, even if it were required, it does not integrate the judicial exceptions because it does not require any actual treatment or prophylaxis of disease, and it does not amount to significantly more because it is merely an instruction to apply the judicial exception but requires no further action.
Response to Remarks
The objection and rejections that were not reiterated were overcome by amendment to the claims.
Applicant argues that the claims do not recite a judicial exception. The claims clearly recite the relationship between gene expression and response to therapy, mathematical calculations, and thinking about the results. These are each judicial exceptions.
Applicant argues that the claims are not directed to a judicial exception because they also recite measuring gene expression (note there is no requirement to measure protein expression, as applicant argues). However, this is a mere data gathering step recited at an extremely high level of generality employing very well known techniques, as discussed in the rejection.
Applicant further argues that the exceptions are “clearly integrated” into a practical application. Essentially applicant argues that the calculation and the relationship between the gene expression and response provide an improvement. However, the judicial exceptions themselves cannot be the improvement in a technical area. The reasons the examiner finds the judicial exceptions are not integrated are given in the Office action.
Applicant argues that the lack of prior art evidences that the claimed methods are not well-understood, conventional, or routine. However, the molecular biology techniques used in the method are demonstrated by the cited prior art to be well understood. The claims are free of the prior art due to the recited judicial exceptions. There are no new technical aspects.
The rejection is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Perez-Magan teaches differential profiling expression analysis to identify markers of recurrence in meningiomas. Relevant to the elected invention, the reference teaches TMEM30B among the genes that were markers of recurrence (p. 1278, 1st column; Perez-Magan et al. Neuro-Oncology 12(12):1278–1290, 2010; doi:10.1093/neuonc/noq081 NEURO-ONCOLOGY; Advance Access publication August 4, 2010). The reference does not teach a method as claimed in claim 1 wherein the expression values of all seven elected genes are assigned scores and together used to predict recurrence of meningioma.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Juliet Switzer whose telephone number is (571)272-0753. The examiner can normally be reached Monday to Thursday, 8:00 AM-3:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Winston Shen can be reached at (571)-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Juliet Switzer
Primary Examiner
Art Unit 1682
/JULIET C SWITZER/Primary Examiner, Art Unit 1682